Evidence map›Paper›PMID 26462271›Full record

ArticleBMJ open gastroenterology2015

VSL#3 induces and maintains short-term clinical response in patients with active microscopic colitis: a two-phase randomised clinical trial.

Sarika Rohatgi, Vineet Ahuja, Govind K Makharia, Tarun Rai, Prasenjit Das, Siddharth Dattagupta, Veena Mishra, Sushil Kumar Garg

Open access · goldAbstract read
In one paragraph

Article in BMJ open gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
1.1field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Probiotics for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Interventions for treating lymphocytic colitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Epithelial wound healing in inflammatory bowel diseases: the next therapeutic frontier.Translational research : the journal of laboratory and clinical medicine · 2021
    Review
  12. Article
  13. Review
  14. Management of microscopic colitis: challenges and solutions.Clinical and experimental gastroenterology · 2019
    Review
  15. Review
  16. Review
  17. Article
  18. Gut microbes
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Sarika RohatgiDepartment of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Vineet AhujaDepartment of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Govind K MakhariaDepartment of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Tarun RaiDepartment of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Prasenjit DasDepartment of Pathology , All India Institute of Medical Sciences , New Delhi , India.
Siddharth DattaguptaDepartment of Pathology , All India Institute of Medical Sciences , New Delhi , India.
Veena MishraDepartment of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Sushil Kumar GargDepartment of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
All India Institute of Medical Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe probiotic mixture VSL#3 has proven efficacious in inflammatory bowel diseases and irritable bowel syndrome; however, its efficacy in microscopic colitis (MC) is being investigated.

objectiveTo evaluate the safety and efficacy of a multistrain probiotic, VSL#3, in inducing clinical remission and achieving clinical response, as compared with mesalamine, in patients with active MC.

methodsA randomised, open labelled study comparing the efficacy of 900 billion colony-forming units/day of VSL#3 (group (Gp) A) or 1.6 g of mesalamine/day (Gp B) for 8 weeks in 30 patients with MC was conducted. After a washout period of 2 weeks, Gp B received 8 weeks of VSL#3 and Gp A was off medication for the next 8 weeks. The primary end points were clinical remission and clinical response at 8 weeks.

resultsOf 30 patients, 15 were randomised in each arm. 11 patients in Gp A and 13 patients in Gp B completed 8 weeks of treatment. 5 (46%) of 11 patients in Gp A and 1 (8%) of 13 patients in Gp B attained clinical remission (p=0.022). Clinical response was seen in Gp A, as evidenced by a lower stool weight (377.6±104.5 g) as compared with Gp B (507±168.2 g; p=0.03). VSL#3 was effective in maintaining clinical response up to 10 weeks, even after discontinuation of therapy. Secondary end points like stool parameters, histology and well-being improved in both treatment groups.

conclusionsThe probiotic VSL#3 was found to offer the benefit of inducing as well as maintaining short-term clinical response in patients with active MC. TRIAL REGISTRATION NUMBER: The clinical trial is registered with CLINICAL TRIAL REGISTRY INDIA; http://ctri.nic.in, CTRI No. "CTRI/2008/091/000086" (registered on: 23/06/2008).

Indexed as

5-AMINOSALICYLIC ACID (5-ASA)MICROSCOPIC COLITISPROBIOTICS

Identifiers

PMID26462271
PMCPMC4599154
OpenAlexW1995159996

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.