Evidence map›Paper›PMID 33501942›Full record

Trial reportInflammatory bowel diseases2021

Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial.

Essi K Karjalainen, Laura Renkonen-Sinisalo, Reetta Satokari, Harri Mustonen, Ari Ristimäki, Perttu Arkkila, Anna H Lepistö

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Inflammatory bowel diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03378921 (Double-blinded Randomized Placebo Controlled Study), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 9% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03378921 phase2completednot on this map

Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis

TypeinterventionalSponsorHelsinki University Central HospitalRan2018 to 2019Enrolled26ConditionsPouchitis, Ulcerative ColitisArmsFecal microbiota transplantation, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. A Systematic Review and Meta-analysis of Randomized Clinical Trials on the Prevention and Treatment of Pouchitis after Ileoanal Pouch Anastomosis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2023
    Pooled it
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Approach to Therapy for Chronic Pouchitis.Annual review of medicine · 2025
    Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Pouchitis: pathophysiology and management.Nature reviews. Gastroenterology & hepatology · 2024
    Review
  20. Current perspectives on fecal microbiota transplantation in inflammatory bowel disease.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Essi K KarjalainenDepartment of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0002-0760-4275
Laura Renkonen-SinisaloDepartment of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.
Reetta SatokariHuman Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Harri MustonenDepartment of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.
Ari RistimäkiDepartment of Pathology, Medicum, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Perttu ArkkilaDepartment of Gastroenterology, Helsinki University Hospital, Helsinki, Finland.
Anna H LepistöDepartment of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.
University of Helsinki · FIHelsinki University Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn ulcerative colitis, a pouchitis is the most common long-term adverse effect after proctocolectomy and ileal pouch-anal anastomosis. Approximately 5% of patients develop chronic antibiotic-dependent or antibiotic-refractory pouchitis without any effective treatment. The aim of this trial was to investigate the efficacy and safety of fecal microbiota transplantation in the treatment of chronic pouchitis.

methodsThis was a single-center, double-blinded, parallel group trial comparing donor fecal microbiota transplantation with placebo (autologous transplant) in chronic pouchitis. Twenty-six patients were recruited at the Helsinki University Hospital between December 2017 and August 2018 and were randomly allocated a 1:1 ratio to either donor fecal microbiota transplantation or placebo. The protocol included 2 transplantations into the pouch on weeks 0 and 4, and patients were followed up for 52 weeks.

resultsNine patients in the intervention group and 8 patients in the placebo group relapsed during the 52-week follow-up, and the relapse-free survival did not differ between the groups (P = 0.183, log-rank; hazard ratio, 1.90 [95% confidence interval, 0.73-4.98; P = 0.190]). In the subgroup analysis of patients using continuous antibiotics before the study, the relapse-free survival was shorter in the intervention group (P = 0.004, log-rank; hazard ratio, 13.08 [95% confidence interval, 1.47-116.60; P = 0.021]). No major adverse effects were reported.

conclusionsThe fecal microbiota transplantation treatment regime used in our study was not effective in the treatment of chronic pouchitis. The safety profile of fecal microbiota transplantation was good. CLINICALTRIALS.GOV IDENTIFIER: NCT03378921.

Indexed as

Colitis, UlcerativeFecal Microbiota TransplantationPouchitisAnti-Bacterial AgentsChronic DiseaseHumansAnti-Bacterial Agentschronic pouchitisfecal microbiota transplantationulcerative colitis

Identifiers

PMID33501942
PMCPMC8528148
OpenAlexW3122001766

What OpenQuestion holds

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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.