Trial reportBMC complementary and alternative medicine2010
Clinical trial: probiotic treatment of acute distal ulcerative colitis with rectally administered Escherichia coli Nissle 1917 (EcN).
Trial report in BMC complementary and alternative medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 13 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
98 citing papers in PubMed, 13 syntheses or guidelines pooled it, 207 citations in OpenAlex.
- Targeting gut microbiota dysbiosis in inflammatory bowel disease: a systematic review of current evidence.Frontiers in medicine · 2025Pooled it
- Efficacy and safety of probiotics in IBD: An overview of systematic reviews and updated meta-analysis of randomized controlled trials.United European gastroenterology journal · 2024Pooled it
- Efficacy and safety of gut microbiota-based therapies in autoimmune and rheumatic diseases: a systematic review and meta-analysis of 80 randomized controlled trials.BMC medicine · 2024Pooled it
- Probiotics as a Coadjuvant Factor in Active or Quiescent Inflammatory Bowel Disease of Adults-A Meta-Analytical Study.Nutrients · 2020Pooled it
- AGA Technical Review on the Role of Probiotics in the Management of Gastrointestinal Disorders.Gastroenterology · 2020Guideline
- Probiotics for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Pooled it
- Probiotic Therapy for Treating Behavioral and Gastrointestinal Symptoms in Autism Spectrum Disorder: A Systematic Review of Clinical Trials.Current medical science · 2019Pooled it
- The Efficacy of Probiotics, Prebiotic Inulin-Type Fructans, and Synbiotics in Human Ulcerative Colitis: A Systematic Review and Meta-Analysis.Nutrients · 2019Pooled it
- Pooled it
- Probiotic treatments for induction and maintenance of remission in inflammatory bowel diseases: a meta-analysis of randomized controlled trials.Clinical journal of gastroenterology · 2014Pooled it
- Nutritional modulators of ulcerative colitis: clinical efficacies and mechanistic view.World journal of gastroenterology · 2013Pooled it
- Pooled it
- Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis.The Korean journal of internal medicine · 2022Trial
- Escherichia coli Nissle 1917 as adjuvant therapy in patients with chronic bacterial prostatitis: a non-blinded, randomized, controlled trial.World journal of urology · 2021Trial
- Update on Diet and Nutritional Therapies in Patients with Inflammatory Bowel Disease.Digestive diseases and sciences · 2026Review
- An Engineered Variant ofACS synthetic biology · 2026Article
- Efficacy of Probiotic Escherichia coli Nissle 1917 in Counteracting Reserpine-induced Depression-like Symptoms and Neuroinflammation in Zebrafish.Indian journal of psychological medicine · 2026Article
- Klebsiella ARO112 promotes microbiota recovery, pathobiont clearance and prevents inflammation in IBD mice.Nature communications · 2025Article
- Probiotics in IBD: Evidence and Perspectives on Patient Health and Disease Management.International journal of molecular sciences · 2025Review
38 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProbiotics are effective in inflammatory bowel diseases. Clinical effectiveness and dose dependency of E. coli Nissle (EcN) enemas were investigated in ulcerative colitis (UC).
methodsIn a double-blind study, 90 patients with moderate distal activity in UC were randomly assigned to treatment with either 40, 20, or 10 ml enemas (N = 24, 23, 23) containing 10E8 EcN/ml or placebo (N = 20). The study medication was taken once daily for at least 2 weeks. After 2, 4 and/or 8 weeks the clinical DAI was assessed together with tolerance to treatment. Patients who reached clinical DAI <or= 2 within that time were regarded as responders.
resultsAccording to ITT analysis the number of responders was not significantly higher in the EcN group than in the placebo group (p = 0.4430, 2-sided). However, the Jonckheere-Terpstra rank correlation for dose-dependent efficacy indicated a significant correlation of per-protocol responder rates (p = 0.0446, 2-sided). Time to remission was shortest with EcN 40 ml, followed by EcN 20 ml. The number of adverse events did not differ notably.
conclusionIn contrast to ITT analysis, efficacy of rectal EcN application was significant in PP and points to EcN as a well tolerated treatment alternative in moderate distal UC.
trial registrationGerman Clinical Trials Register DRK00000234.
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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.