Nutritional care at centres managing patients with inflammatory bowel disease: A nationwide survey in Italy.

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at risk of malnutrition, but little is known about how IBD centres provide nutritional care. AIM: To assess how nutritional care is delivered at IBD centres across Italy. METHODS: 120 IBD centres were invited to answer a web-based questionnaire. RESULTS: 76 questionnaires (63.3%) were completed. An IBD-dedicated nutritionist is present in 27 centres (35.5%). Fifty-two centres (68.4%) have an IBD multidisciplinary team, and 22 of these include a nutritionist. In the outpatient setting, malnutrition risk is evaluated at each visit in 23 centres (30.3%), while nutritional status is assessed at each visit in 21 centres (27.6%). These assessments are performed by a gastroenterologist in almost all centres (93.4% and 88.2%, respectively) and more rarely by a nutritionist (32.9% and 36.9%), dietician (7.9% and 2.6%) or nurse (3.9% and 9.2%). The decision to offer oral nutritional support is made by a gastroenterologist alone (35.5%), a nutritionist alone (23.7%), or a team of the two (38.2%). CONCLUSIONS: Nutritional care for IBD patients appears quite far from satisfactory in the Italian reality. Educational and structural interventions are urgently needed to improve assessment and treatment of malnutrition in everyday clinical practice.

Development and validation of an endoscopic classification of diverticular disease of the colon: the DICA classification.

BACKGROUND: A validated endoscopic classification of diverticular disease (DD) of the colon is lacking at present. Our aim was to develop a simple endoscopic score of DD: the Diverticular Inflammation and Complication Assessment (DICA) score. METHODS: The DICA score for DD resulted in the sum of the scores for the extension of diverticulosis, the number of diverticula per region, the presence and type of inflammation, and the presence and type of complications: DICA 1 (≤ 3), DICA 2 (4-7) and DICA 3 (>7). A comparison with abdominal pain and inflammatory marker expression was also performed. A total of 50 videos of DD patients were reassessed in order to investigate the predictive role of DICA on the outcome of the disease. RESULTS: Overall agreement in using DICA was 0.847 (95% confidence interval, CI, 0.812-0.893): 0.878 (95% CI 0.832-0.895) for DICA 1, 0.765 (95% CI 0.735-0.786) for DICA 2 and 0.891 (95% CI 0.845-0.7923) for DICA 3. Intra-observer agreement (kappa) was 0.91 (95% CI 0.886-0.947). A significant correlation was found between the DICA score and C-reactive protein values (p = 0.0001), as well as between the median pain score and the DICA score (p = 0.0001). With respect to the 50 patients retrospectively reassessed, occurrence/recurrence of disease complications was recorded in 29 patients (58%): 10 (34.5%) were classified as DICA 1 and 19 (65.5%) as DICA 2 (p = 0.036). CONCLUSIONS: The DICA score is a simple, reproducible, validated and easy-to-use endoscopic scoring system for DD of the colon.

Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first "real-life" experience in primary gastroenterology centers in Italy.

BACKGROUND: Adalimumab (ADA) is the key treatment for ulcerative colitis (UC) unresponsive or intolerant to standard treatments. Our aim was to assess the efficacy and safety of ADA in treating ambulatory UC patients in primary gastroenterology centers. METHODS: Fifteen patients (6 male, median age 29.9 years, range 22.8-39.9 years) were enrolled. All were previously treated with infliximab (IFX). Clinical activity and endoscopic severity were scored according to the Crohn's disease activity index (CDAI) score and Mayo subscore for endoscopy, respectively. Patients were clinically assessed at weeks 4, 8, and thereafter at weeks 16, 24, 32, 40, 48, and 54. Colonoscopy was performed before starting treatment, at weeks 24 and 54. The co-primary endpoints were clinical remission at 24 and 54 weeks. The secondary endpoints included: 1) sustained clinical remission; 2) steroid-sparing effect; 3) mucosal healing; 4) need for colectomy. Induction dose of ADA was 160 mg at week 0, and then 80 mg at week 2, while ADA maintenance treatment was 40 mg every two weeks. RESULTS: Clinical remission was obtained in 11 (73.3%) and 15 (100%) patients at weeks 24 and 54 respectively. Ten patients (66.7%) were able to discontinue steroids and were under corticosteroid-free remission at week 54. No patients underwent to colectomy. Eight patients (53.33%) at week 24 and 9 patients (60%) at week 54 achieved complete mucosal healing (Mayo endoscopic score 0). Side effects were reported in 2 of 15 patients (13.3%); none of those patients stopped treatment. CONCLUSION: ADA seems to be effective and safe in UC outpatients affected by UC, and previously treated with IFX.

factors influencing mucosal healing in Crohn's disease during infliximab treatment.

BACKGROUND/AIMS: The effect of infliximab (IFX) on mucosal healing (MH) in clinical setting, as well as what is the effect of scaring of profound ulcers on bowel, is not well known. Aim of our study was to assess how MH occurs in Crohn's disease (CD) in clinical setting during treatment with IFX. METHODOLOGY: Forty patients with CD were followed-up. MH and endoscopic remission (ER) were assessed. Some factors were investigated in predicting development of "uncomplicated" (ulcer healing without alteration of bowel profile) or "complicated" (ulcer healing with alteration of bowel profile) MH. RESULTS: IFX was administered for a mean of 36 months. MH ranged from 67.5% of cases after 6 months to 42.5% of cases after 3 year of treatment. ER ranged from 87.5% of cases after 6 months to 52.5% of cases after 3 year of treatment. Mean CDEIS score decreased from 28 to 8 at the end of follow-up. Uncomplicated MH occurs in 70.37% of patients, complicated MH occurred in 29.63% of patients. Complicated MH was recorded more frequently in patients with severe CDAI (>300 vs. <300, p <0.0362) and higher CDEIS (>35 vs. <35, p >0.0342). CONCLUSIONS: Complicated MH seems to occur frequently in clinical practice when using IFX, especially in patients with higher indexes of activity at entry.

Detection of endoscopic and histological inflammation after an attack of colonic diverticulitis is associated with higher diverticulitis recurrence.

BACKGROUND & AIMS: Colonic diverticulitis shows a high recurrence rate, but the factors associated with such recurrence are still unknown. The aim of our study was to investigate the role of endoscopic and histological inflammation as predictors for the recurrence of diverticulitis. METHODS: One hundred and thirty patients suffering from Acute Uncomplicated Diverticulitis (AUD) (81 males, 49 females, mean age 64.71 years, range 40-85) were prospectively assessed. All patients had AUD confirmed by computerized tomography (CT) and endoscopy. Clinical, endoscopic and histological follow-up was performed after 6, 12 and thereafter 24 months after diagnosis of AUD. RESULTS: Sixteen patients were lost to follow-up. Diverticulitis recurred in 18 patients (13.84%): 15 (13.15%) patients showed recurrence of AUD, whilst 3 (2.63%) showed recurrence of complicated diverticulitis. At the end of the follow-up period, endoscopic inflammation was still detected in 31 (27.67%) patients, and active histological inflammation in 41 patients (36.6 %). Only detection of endoscopic and of histological inflammation during the follow-up was a predictor of diverticulitis recurrence (Log rank test, p = 0.0004). CONCLUSIONS: Detection of endoscopic and histological inflammation after attack of AUD was identified as a predictor of diverticulitis recurrence.

Segmental colitis associated with diverticulosis: a 5-year follow-up.

BACKGROUND AND AIMS: Literature data about the outcome of segmental colitis associated with diverticulosis (SCAD) are scarce. Our aim was to assess the clinical outcome of SCAD according to the type of disease. PATIENTS/METHODS: Twenty-seven SCAD patients underwent a 5-year follow-up (13 males, 14 females; mean age, 63.71 years; range, 50-85 years). Eleven patients were affected by type A, eight by type B, four by type C and four by type D SCAD. During the follow-up, all type B, C, and D patients were under continuous medical treatment. Five type A patients refused any maintaining treatment, but accepted to undergo the clinical, endoscopic, and histological follow-up. RESULTS/FINDINGS: Five type A patients taking therapy (83.33%), two type A not taking therapy (50%), all type C patients (100%), five type B patients (62.5%) and none of type D (0%) were under continuous remission at the end of the follow-up. All type D patients required further steroid course to obtain remission, and two patients required azathioprine to maintain remission. INTERPRETATIONS/CONCLUSIONS: SCAD B and D patients fail to maintain long-term remission, often requiring immunosuppressive treatment. SCAD A and C patients show a more benign course; however, long-term treatment guarantees longer remission also in those patients.

Tumour necrosis factor-alpha expression in segmental colitis associated with diverticulosis down-regulates after treatment.

BACKGROUND AND AIMS: Tumour necrosis factor-α (TNF-α) expression may be increased in segmental colitis associated with diverticulosis (SCAD). Our aim was to assess TNF-α expression in SCAD in relationship to the treatment. METHODS: 10 patients affected by severe (type B and D) SCAD were studied (6 males, 4 females, mean age 60.54 years, range 43-85 years). All patients were treated with beclomethasone dipropionate 10 mg/day plus a probiotic preparation VSL#3 for 8 weeks. At that time, clinical, endoscopic and histological reassessment was performed. Controls were 5 patients with active ulcerative colitis (UC). RESULTS: After treatment, all SCAD B and no SCAD D patients were in remission. The TNF-α expression dropped from 42.7% (+/-7.58) to 15.7% (+/-2.6) in SCAD B patients (p=0.001), and from 40% (+/-5.9) to 28.6% (+/-5.3) in SCAD D patients (p=0.005). In UC patients, the TNF-α expression dropped from 45.5% (+/-5.09) to 22.5% (+/-2.5) (p=0.001). Neither SCAD B nor SCAD D patients showed a significant difference in TNF-α expression compared to UC after treatment. Finally, TNF-α was significantly overexpressed in SCAD D than in SCAD B at the end of treatment (p=0.048). CONCLUSIONS: TNF-α expression in SCAD down regulates after treatment, and seems to be related to the clinical response to therapy. This behaviour, similar to that of Inflammatory Bowel Diseases (IBD), confirms that this disease should be considered as a subtype of IBD.

Tumour necrosis factor-alpha expression in segmental colitis associated with diverticulosis is related to the severity of the endoscopic damage.

BACKGROUND: Tumour necrosis factor-α expression may be increased in segmental colitis associated with diverticulosis. AIMS: To assess tumour necrosis factor-α expression in segmental colitis associated with diverticulosis in relation with the severity of the endoscopic damage. METHODS: 21 patients affected by segmental colitis associated with diverticulosis were studied (15 M, 6 F, mean age 58.87 years, range 43-85 years). Segmental colitis associated with diverticulosis was graduated as mild-moderate (patterns A and C) and severe (patterns B and D). Ten patients with moderate-to-severe ulcerative colitis, 10 patients with moderate-to-severe Crohn's disease, and 10 patients with irritable bowel syndrome served as control groups. RESULTS: Tumour necrosis factor-α expression was significantly higher in segmental colitis associated with diverticulosis B (42.7%) and segmental colitis associated with diverticulosis D (40%) than in segmental colitis associated with diverticulosis A (19.1%) and segmental colitis associated with diverticulosis C (21.1%).Tumour necrosis factor-α expression was lower in segmental colitis associated with diverticulosis A and C than in ulcerative colitis and Crohn's disease, whilst no different tumour necrosis factor-α expression was found between segmental colitis associated with diverticulosis B and D and both ulcerative colitis and Crohn's disease.Finally, tumour necrosis factor-α expression was significantly lower in irritable bowel syndrome (8%±4) than in every type of segmental colitis associated with diverticulosis. CONCLUSIONS: Tumour necrosis factor-α expression in segmental colitis associated with diverticulosis seems to be related to the severity of the endoscopic damage. This behaviour, similar to that of the inflammatory bowel diseases (IBD), confirms that this disease should be considered as a subtype of IBD.

Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study.

OBJECTIVES: VSL#3 is a high-potency probiotic mixture that has been used successfully in the treatment of pouchitis. The primary end point of the study was to assess the effects of supplementation with VSL#3 in patients affected by relapsing ulcerative colitis (UC) who are already under treatment with 5-aminosalicylic acid (ASA) and/or immunosuppressants at stable doses. METHODS: A total of 144 consecutive patients were randomly treated for 8 weeks with VSL#3 at a dose of 3,600 billion CFU/day (71 patients) or with placebo (73 patients). RESULTS: In all, 65 patients in the VSL#3 group and 66 patients in the placebo group completed the study. The decrease in ulcerative colitis disease activity index (UCDAI) scores of 50% or more was higher in the VSL#3 group than in the placebo group (63.1 vs. 40.8; per protocol (PP) P=0.010, confidence interval (CI)95(%) 0.51-0.74; intention to treat (ITT) P=0.031, CI95(%) 0.47-0.69). Significant results with VSL#3 were recorded in an improvement of three points or more in the UCDAI score (60.5% vs. 41.4%; PP P=0.017, CI95(%) 0.51-0.74; ITT P=0.046, CI95(%) 0.47-0.69) and in rectal bleeding (PP P=0.014, CI95(%) 0.46-0.70; ITT P=0.036, CI95(%) 0.41-0.65), whereas stool frequency (PP P=0.202, CI95(%) 0.39-0.63; ITT P=0.229, CI95(%) 0.35-0.57), physician's rate of disease activity (PP P=0.088, CI95(%) 0.34-0.58; ITT P=0.168, CI95(%) 0.31-0.53), and endoscopic scores (PP P=0.086, CI95(%) 0.74-0.92; ITT P=0.366, CI95(%) 0.66-0.86) did not show statistical differences. Remission was higher in the VSL#3 group than in the placebo group (47.7% vs. 32.4%; PP P=0.069, CI95(%) 0.36-0.60; ITT P=0.132, CI95(%) 0.33-0.56). Eight patients on VSL#3 (11.2%) and nine patients on placebo (12.3%) reported mild side effects. CONCLUSIONS: VSL#3 supplementation is safe and able to reduce UCDAI scores in patients affected by relapsing mild-to-moderate UC who are under treatment with 5-ASA and/or immunosuppressants. Moreover, VSL#3 improves rectal bleeding and seems to reinduce remission in relapsing UC patients after 8 weeks of treatment, although these parameters do not reach statistical significance.

Predictive value of serologic markers of degree of histologic damage in acute uncomplicated colonic diverticulitis.

BACKGROUND: Acute uncomplicated diverticulitis (AUD) may show histologic and serologic signs of inflammation. GOALS: To assess whether serologic markers of inflammation may be predictive of abnormal histology in AUD. STUDY: Twenty-one consecutive patients affected by AUD were studied (15 Males, 6 Females, mean age 66.19 y, range 43 to 85 y). Diagnosis of AUD was based on specific endoscopic and CT scan patterns. Several serologic markers were assessed [White blood cells (WBC), Erytro-sedimentation Rate, C-reactive protein (CRP), fibrinogen, α1-acid glycoprotein]. Neutrophilic and lymphocytic inflammatory infiltrate was also scored. RESULTS: WBC was increased in 4/21 pts (19.4%), Erytro-sedimentation Rate in 12/21 pts (57.14%), CRP in 13/21 pts (61.9%), fibrinogen in 5/21 pts (23.8%), and α1-acid glycoprotein in 6/21 pts (28.57%). All serologic markers were related with the degree of histologic damage. In patients scoring 3 in neutrophilic infiltrate (severe active inflammation), all markers showed a statistical significant relation (ranging from P=0.004 for WBC to P=0.00001 for fibrinogen). CRP was the most sensitive marker of mild-moderate histologic damage, as it was increased in 4/10 (40%) patients scoring 0 or 1 in neutrophilic infiltrate (absence of mild active inflammation) (P=0.005). CONCLUSIONS: Serologic markers showed a strict relation with the degree of histologic damage in AUD. Moreover, CRP is the most sensitive marker of mild-moderate histologic damage.

Faecal calprotectin in colonic diverticular disease: a case-control study.

BACKGROUND AND AIMS: Information about faecal calprotectin (FC) in colonic diverticular disease (DD) are lacking. We assessed FC in colonic DD, comparing it with irritable bowel syndrome (IBS) patients and healthy controls. Moreover, we compared FC levels in different degrees of DD and assessed FC in symptomatic DD before and after treatment. MATERIALS AND METHODS: Forty-eight consecutive patients with a new endoscopic diagnosis of DD (16 with asymptomatic diverticulosis, 16 with symptomatic uncomplicated DD, 16 with acute uncomplicated diverticulitis), 16 healthy controls, and 16 IBS patients were studied. FC was assessed by semi-quantitative method and compared with histological inflammation. Moreover, FC was reassessed in symptomatic DD after 8 weeks of treatment. RESULTS/FINDINGS: FC was not increased in healthy controls and IBS patients. No difference was found between asymptomatic diverticulosis, healthy controls, and IBS patients (p = n.s.). We found higher FC values in acute uncomplicated diverticulitis (p < 0.0005) and in symptomatic uncomplicated DD (p < 0.005) than in healthy controls and in IBS patients. FC values correlated with inflammatory infiltrate (p < 0.0005). FC decreased after treatment to normal values both in acute uncomplicated diverticulitis (p < 0.0005) and in symptomatic uncomplicated DD (p < 0.005) after treatment. INTERPRETATIONS/CONCLUSIONS: FC may be useful to detect colonic inflammation in DD and in distinguishing symptomatic DD from IBS, as well as in assessing response to therapy in DD.

Complications in celiac disease under gluten-free diet.

We assessed the onset of malignant and nonmalignant complications in a cohort of celiac disease (CD) patients under gluten-free diet (GFD). Five hundred and forty-nine CD patients were retrospectively assessed. Two hundred and fifty-one (45.7%) showed classical, 262 (47.7%) subclinical, and 36 (6.6%) silent form of CD at the time of the diagnosis. The mean time under GFD was 7.13 years (range 1-15 years). Out of 549 patients, 381 (69.4%) were fully compliant, 112/549 (20.4%) reported less than one dietary transgression/month, and 56/549 (10.2%) reported at least one dietary transgression/month. Out of 549 patients, 18 (3.3%) patients developed complications under GFD (seven malignant and 11 nonmalignant complications). Fourteen patients were previously affected by classical CD (5.6% of the overall patients with classical CD), and four were affected by subclinical CD (1.5% of the overall patients with subclinical CD). None of the patients affected by silent CD developed complications. There was no statistical difference between the mean age of the two groups developing complications (P = n.s.). Complications appeared after a mean time under GFD of 6.5 years in classical CD, and after a mean time of 3.5 years in subclinical CD (P = n.s.). Finally, 6/14 (42.8%) patients with classical CD were not fully compliant to GFD, while 2/4 (50%) of subclinical CD patients were not fully compliant to GFD (P = n.s.). Less than 5% of CD patients may develop complications under GFD. Complications seem to affect more classical CD than subclinical CD, and seem to be irrespective of optimal GFD adherence.

Small bowel adenocarcinoma in a patient with Coeliac disease: A case report.

Coeliac disease is a chronic inflammatory disease of the gut with increased risk of gastrointestinal malignancy. Although enteropathy T-lymphoma is the most common neoplasm in patient affected by coeliac disease, an increased frequency of small bowel carcinoma has been described. We present a case of jejunal carcinoma in a patient suffering for coeliac disease in which gastrointestinal and extraintestinal symptoms of disease developed although he was treated with a gluten-free diet.

Mesalazine and/or Lactobacillus casei in maintaining long-term remission of symptomatic uncomplicated diverticular disease of the colon.

BACKGROUND/AIMS: Four different therapeutic schedules with mesalazine and/or probiotics were assessed in preventing recurrence of symptomatic diverticular disease (DD) of the colon. METHODOLOGY: A prospective, dose-finding study was conducted on 75 patients, enrolled in an open fashion: mesalazine 800mg/daily (group M1) or mesalazine 1.6gr 10 days/month (group M2); mesalazine 800mg/daily + Lactobacillus casei DG 16 billion/day for 10 day/month (group LM1) or mesalazine 1.6gr + Lactobacillus casei DG 16 billion/day for 10 day/month (group LM2); Lactobacillus casei DG 16 billion/day for 10 day/month (group L). RESULTS: Seventy one patients completed the study (94.66%). Sixty six patients (88%) were symptom-free after the 24th month of treatment: 11 of group M1 (on i-t-t: 84% [CI 95%: 55.5-98.8]), 8 of group M2 (on i-t-t: 80% [CI 95%: 44.39-97.48]), 15 of group LM1 (on i-t-t: 93.75% [CI 95%: 69.77-99.84]), 12 of group LM2 (on i-t-t: 92.30% [CI 95%: 63.97-99.81]), 20 in group L (on i-t-t: 86.95% [CI 95%: 66.41-97.22]) (p-ns). Four patients (5.33%) suspended the treatment during the follow-up: all experienced recurrence of symptoms (100%), and 2 of them developed diverticulitis (50%). CONCLUSIONS: Mesalazine and/or Lactobacillus casei seem to be effective in maintaining remission of DD for long-time. Moreover, we found recurrence of the disease and complications in all patients suspending treatments.

Assessment and grading of mucosal inflammation in colonic diverticular disease.

GOAL: The aim of this study was to assess and grade the mucosal inflammatory infiltrate in different degrees of diverticular disease (DD) and to compare them with healthy matched controls. BACKGROUND: Mucosal inflammation in colonic DD has never been investigated. In particular, it is unknown whether inflammation may be found in every degree of DD. MATERIALS AND METHODS: Thirty consecutive patients with a new endoscopic diagnosis of DD (10 with asymptomatic diverticulosis, 10 with symptomatic uncomplicated DD, and 10 with acute uncomplicated diverticulitis) and 10 healthy controls were studied. RESULTS: A neutrophilic inflammatory infiltrate was found only in acute uncomplicated diverticulitis (overall score, 26). The mean lymphocytic cell density was significantly higher in symptomatic DD (median lymphocytic density, 7) and acute uncomplicated diverticulitis (median lymphocytic density, 11). Subdividing the patients according to different degrees of DD, we found higher lymphocytic cell density even in asymptomatic diverticulosis (median lymphocytic density, 6.5) than healthy controls (median lymphocytic density, 4; P<0.02). CONCLUSIONS: We found an increased inflammatory infiltrate in DD according to the degree of the disease and higher than healthy controls. Moreover, also asymptomatic diverticulosis shows higher inflammatory cell density than controls.

Effect of lactoferrin supplementation on the effectiveness and tolerability of a 7-day quadruple therapy after failure of a first attempt to cure Helicobacter pylori infection.

BACKGROUND: Up to 35% of H. pylori-positive patients remain infected after a first eradication attempt. Lactoferrin, a natural anti-bacterial glycoprotein, seems a promising tool in treating H. pylori infection, but it has never been used in second-line treatment. MATERIAL/METHODS: A prospective, randomized study was conducted on 70 consecutive patients with persistent H. pylori infection after failure of the first standard treatment schedule. All patients were randomly treated with ranitidine bismuth citrate (RBC, 400 mg b.d.), esomeprazole (40 mg/day), amoxycillin (1 g t.d), and tinidazole (500 mg b.d.) without (group A) or with (group B) supplementation of bovine lactoferrin (200 mg b.d). One month after conclusion of therapy, endoscopy was performed in those patients for whom the examination was clinically relevant. The remaining patients were checked by 13C-urea breath test. RESULTS: Sixty-seven patients were fully compliant and completed the study (33, i.e. 94.28%, in group A and 34, 97.14%, in group B). One group A patient (2.85%) was excluded for protocol violation and one group B patient (2.85%) was lost to follow-up. H. pylori eradication was obtained in 31/33 (on intention-to-treat: 88.57%, 95%CI: 87-99%) group A patients and in 33/34 (on intention-to-treat: 94.28%, 95%CI: 86-100%) group B patients (p=ns). 16/68 patients (23.53%) experienced side effects (29.41% in group A and 17.64% in group B, p= 0.05). CONCLUSIONS: Lactoferrin supplementation was found effective in reducing side-effect incidence. Moreover, it seems capable of achieving a slight (and not statistically significant) improvement in eradicating H. pylori when used in second-line treatment.

Balsalazide and/or high-potency probiotic mixture (VSL#3) in maintaining remission after attack of acute, uncomplicated diverticulitis of the colon.

BACKGROUND AND AIMS: The role of probiotics in the treatment of diverticulitis is still not known. The aim of our study was to investigate whether balsalazide and/or VSL#3 is effective in preventing diverticulitis recurrence. MATERIALS AND METHODS: In this pilot study, 30 consecutive patients (19 males, 11 females, mean age 60.1 years, range 47-75 years) affected by uncomplicated diverticulitis of the colon were monitored. After obtaining remission, the patients were randomly assigned to one of the following groups as follows: group A, balsalazide 2.25 g daily for 10 days every month plus VSL#3 450 billions/day for 15 days every month and group B, VSL#3 alone 450 billions/day for 15 days every month. Primary end-point was considered the maintaining of remission throughout a 12-month follow-up. Secondary end-points considered were (1) the assessment of the overall scores at the end of the follow-up and (2) the effects of the two different treatments with regards to every symptom assessed. RESULTS/FINDINGS: One group A patient was withdrawn from the study at the 6th month and one group B patient was lost at the 6th month of follow-up. One group A patient (6.66%) showed relapse of symptoms at the 10th month of follow-up. At the end of follow-up, 11 patients were completely symptom-free (73.33%), whilst 2 patients complained of only mild, recurrent symptoms (13%). Two group B patients (13.33%) showed relapse of the disease at the 5th and 8th month of follow-up, respectively. At the end of follow-up, 8 patients were completely symptom-free (60%), 2 patients complained of mild, recurrent symptoms (13.33%), 1 patient (6.66%) complained of mild but continuous symptoms. No side effects were recorded throughout the follow-up in both groups. INTERPRETATION/CONCLUSIONS: Combination probiotic/anti-inflammatory drug was found better than probiotic treatment in preventing relapse of uncomplicated diverticulitis of the colon, even if without statistical significance.

Continuous versus cyclic mesalazine therapy for patients affected by recurrent symptomatic uncomplicated diverticular disease of the colon.

Forty consecutive patients affected by recurrent attacks of symptomatic uncomplicated diverticular disease of the colon were evaluated to investigate the effectiveness of 2 different mesalazine therapeutic schedules in preventing recurrence of the disease. The patients were randomly enrolled and treated with mesalazine 1.6 g/d (group A) or mesalazine 1.6 g/d 10 days per month (group B). Thirty-four patients completed the study (85%): 3 (7.5%, 1 in group A and 2 in group B) were lost to follow-up, 2 (5%, both group B) were withdrawn from the study for protocol violation, and 1 (2.5%) for hospital admission for stroke (group A). Twenty-three patients (67.65%) were symptom free after 24 months of treatment (overall symptomatic score, 0): 14 of 18 in group A (per-protocol, 77.78%; intention to treat, 70% [95% confidence interval [CI], 61.5-91.8]), 9 of 16 in group B (per protocol, 56.25%; intention to treat, 45% [95% CI, 61.5-91.8]; P < 0.05). Four patients (10%) improved, but were not completely symptom free. Six patients (15%) showed recurrence of symptoms: 1 in group A (5.56%) and 5 in group B (31.25%; P < 0.005; overall symptomatic score, 68). Daily mesalazine supplying seems to be more effective than cyclic supplying in maintaining remission in recurrent symptomatic uncomplicated diverticular disease.