Evidence map›Paper›PMID 31877418›Full record

Trial reportEBioMedicine2020

The effect of fecal microbiota transplantation on IBS related quality of life and fatigue in moderate to severe non-constipated irritable bowel: Secondary endpoints of a double blind, randomized, placebo-controlled trial.

Peter Holger Johnsen, Frank Hilpüsch, Per Christian Valle, Rasmus Goll

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
5.6field-weighted citation impact, top 4% 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

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  10. [Brain-Gut-Microbiota Axis].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2023
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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

4 authors at 2 institutions in 1 country.

Peter Holger JohnsenUniversity Hospital of North Norway Harstad, Harstad, Norway; UIT The Arctic University of Norway, Tromsø, Norway. Electronic address: peter.holger.johnsen@unn.no.
Frank HilpüschSjøkanten Legesenter, Harstad, Norway; Norwegian Centre of Rural Medicine, UIT Arctic University of Norway, Norway.
Per Christian ValleUniversity Hospital of North Norway Harstad, Harstad, Norway.
Rasmus GollUniversity Hospital of North Norway Tromsø, Tromsø, Norway; UIT The Arctic University of Norway, Tromsø, Norway.
University Hospital of North Norway · NORuralis - Institute for Rural and Regional Research · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeverity in irritable bowel syndrome (IBS) is associated to impaired quality of life and fatigue. Fecal microbiota transplantation (FMT) induces significant relief in gastro-intestinal related complaints. The objective was to evaluate the effect of FMT on the secondary endpoints: IBS-related quality of life and fatigue in patients with non-constipated IBS.

methodIn this double-blind randomized placebo-controlled, parallel-group, single-center study, we enrolled patients with non-constipated IBS, defined by the ROME 3 criteria. We randomly assigned participants (2:1) in blocks of six to active or placebo FMT. Responder in fatigue and quality of life were defined as a decrease of 20 points in total Fatigue Impact Scale score, and improvement of 14 points in the IBS-quality of life questionnaire, respectively. In a modified-intention-to-treat population, we excluded participants who did not undergo treatment or who were diagnosed with any other disease by pinch biopsies during the treatment procedure.

findingsBetween Jan1, and Oct 30, 2015, we recruited 90 participants and randomly assigned them to active treatment (n = 60) or placebo (n = 30). Three participants did not undergo FMT and four were excluded after diagnosis of microscopic colitis, leaving 83 for final modified intention-to-treat analysis (55 in the active treatment group and 28 in the placebo group). Significant improvement in QoL (Odds ratio (OR) 3,801; confidence interval (CI) = 1,309-11,042 p = 0.011) and fatigue (OR = 4,398; CI = 1,175-16,468 and p = 0,020) was found at six months. Absence of other self reported functional disorders and presence of depression at baseline is suggested to predict a lasting effect of FMT in QoL and fatigue, respectively.

interpretationFMT induced significant relief in quality of life and fatigue. Results suggest a lasting effect of FMT in subgroups that should be further investigated in future studies. Funding Helse Nord, Norway and the Norwegian Centre of Rural Medicine, University of Tromsø, Norway.

Indexed as

FatigueFecal Microbiota TransplantationQuality of LifeAdultComorbidityFemaleHumansIrritable Bowel SyndromeMaleMiddle AgedOdds RatioSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeBacterio therapyClinical trialFatigueFecal microbiota transplantationIrritable bowel syndromeQuality of life

Identifiers

PMID31877418
PMCPMC6931102
OpenAlexW2998185126

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.