Double blind placebo-controlled trial for the prevention of ulcerative colitis relapses by β-fructan prebiotics: efficacy and metabolomic analysis
Bibliographic record
Abstract
Background Ulcerative colitis (UC) is associated with altered intestinal microbiome (‘dysbiosis’), most significantly, reduced strict butyrate-producing anaerobes and increased facultative anaerobes. Inulin-type prebiotics appear to reduce and prevent colitis in preclinical studies and small clinical trials. However, these results need to be validated in randomized controlled clinical trial (RCT) studies. Aims The aim of this RCT study was to assess the efficacy of β-fructans (oligofructose and inulin) in preventing relapses in UC patients in clinical remission as well as identify potential mechanisms of activity. Methods Adult UC patients in clinical remission (total Mayo score ≤ 2) were randomized to supplement their diet with 15g/d of either β-fructans (oligofructose and inulin; Synergy1/Prebiotin) or placebo (maltodextrin) for 6 months. Partial Mayo scores, medications, adverse events and intervention compliance were monitored monthly. Fecal specimens were collected throughout the study to measure fecal calprotectin (FCP), along with stool metabolites. Results Eighty-nine UC patients in clinical remission were randomized to β-fructans (n=43) or placebo (n=46). Of those, 11 participants never started, 2 were withdrawn, and 76 were included in the study population (β-fructans n=35; placebo n=41). Although there was no difference in symptomatic clinical flare (β-fructans n=11 flare; placebo n=10 flare, P=0.60), patients randomized to oligofructose and inulin showed only a 3-fold median FCP increase versus 17-fold in the placebo group (P=0.038). Interestingly, antibiotics and serotonin reuptake inhibitors significantly increased the relative risk (RR) of flare (RR 3.321, 95% Cl 2.005 to 5.344, P < 0.0001). β-Fructan intake significantly increased anti-inflammatory fecal metabolites (arabinose, L-arabitol, 5-oxo-D-proline). Conclusions Although oligofructose and inulin did not prevent symptomatic relapses in UC patients, their oral administration significantly reduced the severity of biochemical relapse compared to placebo which was further associated with increased anti-inflammatory metabolites.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".