ABSTRACT
INTRODUCTION: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant's baseline, usual diet (UD). METHODS: Across 19 sites, we recruited patients aged 7-18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets. RESULTS: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was <1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was -0.3 (95% credible interval -1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not. DISCUSSION: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness.
Subject(s)
Colitis, Ulcerative , Crohn Disease , Leukocyte L1 Antigen Complex , Adolescent , Bayes Theorem , Child , Colitis, Ulcerative/complications , Colitis, Ulcerative/diet therapy , Crohn Disease/complications , Crohn Disease/diet therapy , Diet , Feces/chemistry , Humans , Inflammation/complications , Inflammation/diet therapy , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/diet therapy , Leukocyte L1 Antigen Complex/analysis , Precision MedicineABSTRACT
BACKGROUND: Rapid 1-hour infliximab infusions have been safely implemented in adults, but studies of these rapid infusions in pediatric patients are limited. This study's primary objective was to determine the safety of 1-hour infliximab infusions compared with standard 2- to 3-hour infusions in children with inflammatory bowel disease and other autoimmune disorders. METHODS: We conducted an institutional review board-approved prospective study using an unmatched historical control group at a freestanding children's hospital comparing rapid vs standard infusion rates of infliximab and the use of premedications and immunomodulatory agents on the frequency of early and delayed infusion reactions. RESULTS: There were 50 subjects with 540 total standard (2- to 3-hour) infusions in the retrospective group and 66 subjects with 545 total rapid (1-hour) infusions assessed in the prospective group. Although the prospective group received a significantly higher infliximab dose, was significantly less likely to receive premedication, and was significantly more likely to receive another immunomodulatory agent, only 2 instances of potential infusion reactions occurred in the 545 rapid infusions (0.36%; 95% confidence interval [CI], 0.22%-11.01%; 3% of patients) administered in the prospective group compared with 1 documented infusion reaction (0.19%; 95% CI, 0.0%-11.47%; 2% of patients) in the retrospective group (odds ratio, 0.65; 95% CI, 0.01-12.93; P = 0.99). CONCLUSIONS: This study suggests that rapid infusion of infliximab over 1 hour is not associated with an increased risk of infusion reactions when compared with standard 2- to 3-hour infusions and can be safely used in children with no previous reaction to standard infusions to treat inflammatory bowel disease and other autoimmune diseases.
