Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2025
A Pilot Randomized Control Trial to Assess the Adjunctive Effect of Diet on Response to Advanced Therapies in Patients With Ulcerative Colitis.
Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- A Fasting-Mimicking Diet Affects the Inflammatory Response Following Periodontal Treatment: A Multi-centre Feasibility Randomised Controlled Pilot Trial.Journal of clinical periodontology · 2026Trial
- A fasting-mimicking diet in patients with mild-to-moderate Crohn's disease: a randomized controlled trial.Nature medicine · 2026Trial
- Diet and Gut Microbiota in Inflammatory Bowel Disease: A Clinical and Nutritional Perspective.Pharmaceuticals (Basel, Switzerland) · 2026Review
Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
BACKGROUND &
aimsDiet may influence ulcerative colitis (UC), but its impact on medication response remains unclear. We examined whether two 5-day cycles of a low-calorie, plant-based (LC-PB), fasting-mimicking diet could improve UC response to medications in a controlled trial.
methodsAdults with active UC starting advanced therapies were randomized to an LC-PB diet + therapy or a control diet + therapy. The LC-PB diet provided 1090 kcal on day 1 and 725 kcal on days 2-5. The Simple Clinical Colitis Activity Index (SCCAI) was assessed at baseline and week 8. The study, planned for 60 patients, ended early due to COVID-19. The primary endpoint was clinical response (week 8, SCCAI decrease ≥3). Secondary outcomes were clinical improvement (change in SCCAI from baseline), steroid tapering, C-reactive protein, serum amyloid A (SAA), and fecal calprotectin.
resultsOf 32 enrolled patients, 23 completed the study. In the intention-to-treat analysis, 57% (n = 8 of 14) in the LC-PB arm achieved clinical response by week 8 vs 35% (n = 6 of 17) in control arm (P = .11). Secondary analyses indicated greater clinical improvement, measured as continuous SCCAI, in the LC-PB group compared with the control group (P = .039). The LC-PB group had better SCCAI subscores (ie, urgency, well-being), had reductions in SAA, and were tapered off steroids compared with the control group. Mean C-reactive protein and fecal calprotectin decreased more in the LC-PB group, but results were not significant. There were no serious adverse events relating to the diet and no weight loss.
conclusionsThe LC-PB diet did not improve clinical response to medications. However, it led to clinical improvement, steroid tapering, and reduced SAA. As results were limited by sample size, larger studies are needed.
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