Trial reportGut2016
Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial.
Trial report in Gut, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01278082 (Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis
Who cites it
38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Heterogeneity in Histological Evaluation of Microscopic Colitis in Randomized Clinical Trials: An Umbrella Review.Inflammatory bowel diseases · 2026Pooled it
- Interventions for treating collagenous colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Budesonide as induction therapy for incomplete microscopic colitis: A randomised, placebo-controlled multicentre trial.United European gastroenterology journal · 2021Trial
- Smoking Status Influences Clinical Outcome in Collagenous Colitis.Journal of Crohn's & colitis · 2016Trial
- Water-triggered in-situ gelling phospholipid oil enema for enhanced budesonide delivery and mucosal healing in ulcerative colitis.International journal of pharmaceutics: X · 2026Article
- Plasma FABP2, IL-10, and LPS in Microscopic Colitis: An Exploratory Study of Their Biomarker Potential.Medicina (Kaunas, Lithuania) · 2026Article
- Detection of collagen band-associated regions in H&E-stained colonic biopsies of collagenous colitis patients using superpixel-based feature extraction and neural network classification.Diagnostic pathology · 2026Article
- Drugs in focus: Budesonide and its role in paediatric gastrointestinal disorders.Journal of pediatric gastroenterology and nutrition · 2026Review
- Development and validation of a novel patient-reported outcome for microscopic colitis-Microscopic Colitis Score (MCS).Journal of Crohn's & colitis · 2025Article
- Update on the Epidemiology and Management of Microscopic Colitis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025Review
- Open-capsule budesonide for the treatment of immune-related enteritis from checkpoint inhibitors.Journal for immunotherapy of cancer · 2024Article
- Prescribed cumulative dosage of corticosteroids to patients with inflammatory bowel disease diagnosed between 2006 and 2020: a retrospective observational study.Therapeutic advances in gastroenterology · 2024Article
- The natural history of histological changes in microscopic colitis.Therapeutic advances in gastroenterology · 2023Article
- Efficacy and safety of medical therapies in microscopic colitis: a systematic review and network meta-analysis.Therapeutic advances in gastroenterology · 2023Article
- Article
- Diagnosis and Management of Microscopic Colitis in Pediatric Patients.Paediatric drugs · 2022Review
- Vedolizumab blocks α4β7 integrin-mediated T cell adhesion to MAdCAM-1 in microscopic colitis.Therapeutic advances in gastroenterology · 2022Article
- European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations.United European gastroenterology journal · 2021Article
- Serotonin in the Pathogenesis of Lymphocytic Colitis.Journal of clinical medicine · 2021Article
- Distribution of histopathological features along the colon in microscopic colitis.International journal of colorectal disease · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors at 14 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.
designA prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase.
resultsClinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious.
conclusionsBudesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation. TRIAL REGISTRATION NUMBERS: http://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.