Association of bile acid diarrhea with symptoms and disease activity in Crohn’s disease: post-hoc clinical trial analysis of serum 7a-hydroxy-4cholestern-3-one, C4, in patients with active Crohn’s disease
Bibliographic record
Abstract
BACKGROUND AND AIMS: In Crohn's disease (CD), symptomatic and endoscopic assessments often show poor correlation. Bile acid malabsorption is a common comorbidity in these patients and often results in bile acid diarrhea (BAD). This post-hoc clinical trial analysis evaluated BAD presence and its association with symptoms and disease activity in patients with active CD. METHODS: The bile acid precursor, serum 7a-hydroxy-4cholestern-3-one (C4), was analyzed before and after adalimumab therapy in patients with moderate to severe CD. Patients were stratified by C4 concentration to evaluate the association of BAD with symptomatic and endoscopic disease activity. RESULTS: Elevated baseline serum C4 (C4 ≥ 48.3 ng/mL) was present in 37.1% of patients with active CD, was most frequently associated with isolated ileal disease, and persistent in many patients after treatment. Compared to C4 concentrations maintained within the normal range, persistently elevated C4 ≥ 48.3 ng/mL was associated with reduced stool frequency/abdominal pain score (SF/APS) clinical remission (23.9% vs 55.9%, P < .001), and SF remission (28.3% vs 67.7%, P < .001), but not endoscopic remission (43.5% vs 53.1%). In patients with endoscopic remission, those with C4 ≥ 48.3 ng/mL demonstrated reduced SF/APS clinical remission (28.0% vs 51.0%) and SF remission (36.0% vs 67.7%), but similar AP remission (72.0% vs 70.8%) compared to those with normal C4 concentration. CONCLUSIONS: In active CD, BAD was prevalent, particularly in isolated ileal disease, and associated with persistent diarrhea, but not endoscopic remission after treatment. These findings shed light on the discordance between symptomatic and endoscopic assessments observed in CD clinical trials and the challenges in treating isolated ileal disease. ClinicalTrials.gov NCT02065570.
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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 | 0.007 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".