BetaEntity Annotation Prototype
← Back to institutions

Annotated abstract

P202 Patient-reported disease control in a randomised crossover trial of 2′-fucosyllactose in mild-to-moderate ulcerative colitis

gutjnl · 2026-06-23 · canonical JSON source

8 visible annotations · policy: published · automated confidence ≥ 75.00%

Document resource

Introduction Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC) was an adequately powered, randomised double-blind placebo-controlled crossover design clinical trial which assessed the effect of the human milk oligosaccharide (HMO) 2’-fucosyllactose (2’-FL) in mild-to-moderate UC (NCT06050811).Methods 38 participants with mild-to-moderate UC and objective inflammation (elevated CRP or faecal calprotectin or recent endoscopic evidence of activity) were recruited. Participants consumed both 28 days of 5g 2’-FL per day and 28 days of 5g maltodextrin (MDX) placebo per day during the 14 week trial, with a 21 day washout period between treatment periods. Participants were randomised as to which of 2’-FL or MDX they consumed first.Validated patient-reported outcome measures were recorded and faeces, serum and urine were sampled pre- and post- each intervention. Clinical response was the primary outcome as defined by a reduction in Simple Clinical Colitis Activity Index (SCCAI) of ≥2; secondary outcomes were clinical remission, patient perceived disease control (IBD-Control-8), and changes in the gut microbiota and cross-biofluid metabolomic signatures.Results 2’-FL was well adhered to, with no difference in adverse effects nor dropout between 2’-FL and MDX. No evidence of carryover effects was observed.No significant difference was seen in the primary outcome of clinical response from pre- to post- intervention (2’-FL vs MDX, 18.5% vs 29.6%, p = 0.11), nor clinical remission (2’-FL vs MDX, 25.9% vs 18.5%, p = 0.32).IBD-Control-8 scores improved from pre-to-post during 2’-FL supplementation (1.44 point increase, 95% confidence interval 0.19-2.70, p = 0.025), although no significant treatment effect vs placebo was seen. A mean decrease in faecal calprotectin from 342 to 296 μg/g was seen with 2’-FL vs an increase from 269 to 280 μg/g with MDX, but these changes did not reach statistical significance (p = 0.4 and p = 0.84 respectively).Conclusions This is the first randomised clinical trial of an HMO in UC, and the largest crossover trial of a prebiotic in inflammatory bowel disease to date. Improvements in patient-reported disease control in mild-to-moderate UC were observed during 2’-FL exposure.Abstract P202 Figure 1IBD control-8 scores before and after 2’-FL supplementation in the per protocol population