Efficacy of a new nutraceutical formulation: L-tryptophan, probiotics, charcoal, chamomile, mint, and licorice (COLONIR®) in the improvement of gastrointestinal symptoms in subjects with irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders. IBS is characterized by recurrent chronic abdominal pain and altered bowel habits in the absence of organic damage. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS presentation make treatment difficult. Treatment of IBS focuses on relieving symptoms as mild signs and symptoms can often be controlled by managing stress and by making changes in diet and lifestyle. The use of nutraceutical compounds has been advocated as a possible alternative treatment in patients with IBS. COLONIR® (Omega Pharma Srl, Milan, Italy) may be an alternative or adjuvant treatment in patients with gastrointestinal symptoms. This study aimed to evaluate the effect of this new nutraceutical formulation in inducing symptoms remission and improve gastrointestinal habits. METHODS: An initial cohort of 1004 consecutive patients referred to 25 different Units of Internal Medicine a/o Gastroenterology in Italy to perform colonoscopy for intestinal symptoms was asked to participate. Patients were treated for 2 months with two doses of nutraceuticals/day during meals namely COLONIR®. Patients were assessed at baseline and after 2 months to evaluate the frequency and severity of gastrointestinal symptoms in the past seven days with a questionnaire based on ROMA IV criteria. RESULTS: After 2 months, 899 patients completed the follow-up. COLONIR® achieved a statistically significant reduction of severity of symptoms in the study population without any documented side effects. CONCLUSIONS: These promising results, here reported, need to be confirmed, valuating the efficacy of COLONIR® in relieving gastrointestinal symptoms in IBS patients in further studies.

A risk score system to timely manage treatment in Crohn's disease: a cohort study.

BACKGROUND: Clinical severity and intestinal lesions of Crohn's disease (CD) usually progress over time and require a step up adjustment of the therapy either to prevent or to treat complications. The aim of the study was to  develop a simple risk scoring system to assess in individual CD patients the risk of disease progression and the need for more intensive treatment and monitoring. METHODS: Prospective cohort study (January 2002-September 2014) including 160 CD patients (93 female, median age 31 years; disease behavior (B)1 25%, B2 55.6%, B3 19.4%; location (L)1 61%, L3 31.9%, L2 6%; L4 0.6%; perianal disease 28.8%) seen at 6-12-month interval. Median follow-up 7.9 years (IQR: 4.3-10.5 years). Poisson models were used to evaluate predictors, at each clinical assessment, of having the following outcomes at the subsequent clinical assessment a) use of steroids; b) start of azathioprine; c) start of anti-TNF-α drugs; d) need of surgery. For each outcome 32 variables, including demographic and clinical characteristics of patients and assessment of CD intestinal lesions and complications, were evaluated as potential predictors. The predictors included in the model were chosen by a backward selection. Risk scores were calculated taking for each predictor the integer part of the Poisson model parameter. RESULTS: Considering 1464 clinical assessments 12 independent risk factors were identified, CD lesions, age at diagnosis < 40 years, stricturing behavior (B2), specific intestinal symptoms, female gender, BMI < 21, CDAI> 50, presence of inflammatory markers, no previous surgery or presence of termino-terminal anastomosis, current use of corticosteroid, no corticosteroid at first flare-up. Six of these predicted steroids use (score 0-9), three to start azathioprine (score 0-4); three to start anti-TNF-α drugs (score 0-4); six need of surgery (score 0-11). The predicted percentage risk to be treated with surgery within one year since the referral assessment varied from 1 to 28%; with azathioprine from 3 to 13%; with anti-TNF-α drugs from 2 to 15%. CONCLUSIONS: These scores may provide a useful clinical tool for clinicians in the prognostic assessment and treatment adjustment of Crohn's disease in any individual patient.

Small intestine contrast ultrasonography in pediatric Crohn's disease.

OBJECTIVE: To evaluate the diagnostic accuracy of small intestine contrast ultrasonography (SICUS) in pediatric Crohn's disease (CD). STUDY DESIGN: A total of 51 consecutive patients (median age 15 years; range 3-20, 31 male patients), 21 with suspected and 30 with proven CD, were studied. All patients underwent standard ultrasonography (ie, transabdominal ultrasonography [TUS]), SICUS, small bowel follow-through, and upper and lower endoscopy. SICUS was performed in patients after they ingested an oral contrast solution. TUS and SICUS were compared with small bowel follow-through and endoscopy via use of the final diagnosis as reference standard. RESULTS: In undiagnosed patients, the sensitivity and specificity of TUS and SICUS in detecting CD small bowel lesions were 75% and 100% and 100% and 100%, respectively. In patients with proven CD, the sensitivity and specificity of TUS and SICUS were 76% and 100% and 96% and 100%, respectively. The agreement (k) with radiology for site of lesions was almost perfect for SICUS (0.93), both for jejunal and ileal lesions, and it was fair (0.40) for jejunal and substantial (0.68) for ileal lesions for TUS. Compared with radiology SICUS correctly assessed the length of lesions, whereas TUS underestimated it (P = .0001). CONCLUSIONS: The radiation-free technique SICUS is comparable with radiology and more accurate than TUS in assessing small bowel lesions in pediatric CD, mainly in the detection of proximal small bowel disease.

Small intestine contrast ultrasonography (SICUS) for the detection of small bowel complications in crohn's disease: a prospective comparative study versus intraoperative findings.

BACKGROUND: In Crohn's disease (CD) patients, small intestine contrast ultrasonography (SICUS) accurately assesses small bowel lesions. Its diagnostic role is not known in the assessment of intraabdominal CD complications. The aim was to assess the value of SICUS to detect intestinal complications in patients with CD. METHODS: Forty-nine CD patients (21 female, mean age 37.7 years; range 12-78 years) underwent resective bowel surgery and were included in this study. The accuracy of SICUS to preoperatively detect number, site, and length of strictures, fistulas, and abscesses was compared with surgical and pathological findings by kappa statistics. RESULTS: SICUS identified at least one stricture in 39/40 and excluded it in 9/9 (97.5% sensitivity, 100% specificity, k = 0.93); two or more strictures in 9/12 (75% sensitivity, 100% specificity, k = 0.78). The agreement by k-statistics between SICUS and surgery in identifying proximal and distal small intestine site of stricture was 1 and 0.92, respectively. The extension of strictures was 6.8 ± 5.4 cm at surgery, 6.6 ± 5.4 cm at SICUS (NS). Fistulas were correctly identified in 27/28 patients and excluded in 19/21 patients (96% sensitivity, 90.5% specificity, k = 0.88). Intraabdominal abscesses were correctly detected in 10/10 patients and excluded in 37/39 patients (100% sensitivity, 95% specificity, k = 0.89). CONCLUSIONS: SICUS is an accurate method for the detection of small intestinal complications in CD. Noninvasive SICUS is valuable as a primary investigative method for evaluating and planning proper treatment in patients with severe CD of the small bowel.

Ultrasonographic detection and assessment of the severity of Crohn's disease recurrence after ileal resection.

BACKGROUND: Recurrence and severity of Crohn's disease mucosal lesions after "curative" ileal resection is assessed at endoscopy. Intramural lesions can be detected as increased wall thickness at Small Intestine Contrast Ultrasonography (SICUS). AIMS: To assess after ileal resection whether: 1) SICUS detects recurrence of Crohn's disease lesions, 2) the intestinal wall thickness measured at the level of ileo-colonic anastomosis predicts the severity of endoscopic lesions, 3) the extension of intramural lesions of the neo-terminal ileum is useful for grading severity of the recurrence, 4) the combined measures of wall thickness of the ileo-colonic anastomosis and of the extension of intramural lesions at level of the neo-terminal ileum may predict the endoscopic Rutgeerts score METHODS: Fifty eight Crohn's disease patients (M 37, age range 19-75 yrs) were prospectively submitted at 6-12 months intervals after surgery to endoscopy and SICUS for a total of 111 observations. RESULTS: Six months or more after surgery wall thickness of ileo-colonic anastomosis > 3.5 mm identified 100% of patients with endoscopic lesions (p < 0.0001). ROC curve analysis, combining wall thickness of ileo-colonic anastomosis and the extension of intramural lesions of neo-terminal ileum, discriminated (0.95) patients with, from those without, endoscopic lesions. Performing two multiple logistic regression analyses only wall thickness of ileo-colonic anastomosis and extension of neo-terminal ileum intramural lesions were significantly associated with absence or presence of endoscopic lesions. An ordinal polychotomus logistic model, considering all investigated variables, confirmed that only SICUS variables were associated with endoscopic grading of severity. CONCLUSIONS: In patients submitted to ileal resection for Crohn's disease non-invasive Small Intestine Contrast Ultrasonography 1) by assessing thickness of ileo-colonic anastomosis accurately detects initial, minimal Crohn's disease recurrence, and 2) by assessing both thickness of ileo-colonic anastomosis and extension of intramural lesions of neo-terminal ileum grades the severity of the post-surgical recurrence.

Effect of infliximab on small bowel stenoses in patients with Crohn's disease.

AIM: To assess prospectively small bowel stenoses in Crohn's disease (CD) patients treated with infliximab using Small Intestine Contrast Ultrasonography (SICUS). METHODS: Twenty patients (M 12, age, 42.7 +/- 11.8 years), 15 of whom showed obstructive symptoms indicating the presence of small bowel stenosis, and 5 without stenosis, were treated with infliximab (5 mg/kg at wk 0, 2, 6 and 5 mg/kg every 8 wk thereafter) for steroid refractoriness, fistulizing disease, or to avoid high-risk surgery. SICUS was performed at the induction phase and at regular time intervals during the follow-up period of 34.7 +/- 16.1 mo (range 7-58). Small bowel stenoses were detected by SICUS, endoscopy and MRI. RESULTS: In no case was progression of stenoses or the appearance of new ones seen. Of the 15 patients with stenosis, 5 stopped treatment after the induction phase (2 for no response, 3 for drug intolerance, one of whom showed complete regression of one stenosis). Among the remaining 10 patients, a complete regression of 8 stenoses (1 stenosis in 5 patients and 3 stenoses in one patient) was observed after 6-22 infliximab infusions. CONCLUSION: In patients with CD treated with infliximab we observed: (a) No progression of small bowel stenosis and no appearance of new ones, (b) Complete regression of 1/22 stenosis after the induction phase and of 8/15 (53.3%) stenosis after 6-22 infusions during maintenance therapy.