Evidence map›Paper›PMID 34226737›Full record

Trial reportNature medicine2021

Fecal microbial transplantation and fiber supplementation in patients with severe obesity and metabolic syndrome: a randomized double-blind, placebo-controlled phase 2 trial.

Valentin Mocanu, Zhengxiao Zhang, Edward C Deehan, Dina H Kao, Naomi Hotte, Shahzeer Karmali, Daniel W Birch, Kalutota K Samarasinghe, Jens Walter, Karen L Madsen

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03477916 (Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.), which is not on this map. Cited by 184 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
184citing papers in PubMed, 8 pooled it
24.7field-weighted citation impact, top 1% 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.

NCT03477916 phase2completednot on this map

Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.

TypeinterventionalSponsorUniversity of AlbertaRan2018 to 2020Enrolled68ConditionsObesity, Metabolic SyndromeArmsFMT, Placebo FMT, Prebiotic Fiber, Cellulose
3 · Its place in the literature

Who cites it

184 citing papers in PubMed, 8 syntheses or guidelines pooled it, 289 citations in OpenAlex.

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  5. Roles of the gut microbiome in weight management.Nature reviews. Microbiology · 2023
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124 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 3 countries.

Valentin MocanuDepartment of Surgery, University of Alberta, Edmonton, Alberta, Canada.
Zhengxiao ZhangDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Edward C DeehanDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Dina H KaoDivision of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Naomi HotteDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Shahzeer KarmaliDepartment of Surgery, University of Alberta, Edmonton, Alberta, Canada.
Daniel W BirchDepartment of Surgery, University of Alberta, Edmonton, Alberta, Canada.
Kalutota K SamarasingheFaculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.ORCID http://orcid.org/0000-0002-4173-4161
Jens WalterAPC Microbiome Ireland, School of Microbiology and Department of Medicine, University College Cork, Cork, Ireland.
Karen L MadsenDivision of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. kmadsen@ualberta.ca.ORCID http://orcid.org/0000-0002-8636-0714
University of Alberta · CAUniversity College Cork · IE

Funding

CIHR
6 · The paper itself

Abstract

Fecal microbial transplantation (FMT) from lean donors to patients with obesity has been associated with metabolic benefits, yet results so far have been inconsistent. In this study, we tested the application of daily fiber supplementation as an adjunct to FMT therapy to modulate cardiometabolic outcomes. We performed a double-blind randomized trial in patients with severe obesity and metabolic syndrome receiving oral FMT, to test high-fermentable (HF) and low-fermentable (LF) fiber supplements (NCT03477916). Seventy participants were randomized to the FMT-HF (n = 17), FMT-LF (n = 17), HF (n = 17) and LF (n = 19) groups. The primary outcome was the assessment of change in insulin sensitivity from baseline to 6 weeks using the homeostatic model assessment (HOMA2-IR/IS). After 6 weeks, only patients in the FMT-LF group had significant improvements in HOMA2-IR (3.16 ± 3.01 at 6 weeks versus 3.77 ± 3.57 at baseline; P = 0.02). No difference in HOMA2-IR was observed over this period for those in the FMT-HF group (3.25 ± 1.70 at 6 weeks versus 3.17 ± 1.72 at baseline; P = 0.8), the HF group (3.49 ± 1.43 at 6 weeks versus 3.26 ± 1.33 at baseline; P = 0.8) or the LF group (3.76 ± 2.01 at 6 weeks versus 3.56 ± 1.81 at baseline; P = 0.8). Interventions were safe and well-tolerated with no treatment-attributed serious adverse events. We provide proof of concept for the use of a single-dose oral FMT combined with daily low-fermentable fiber supplementation to improve insulin sensitivity in patients with severe obesity and metabolic syndrome.

Indexed as

Dietary FiberDietary SupplementsDouble-Blind MethodFecal Microbiota TransplantationFemaleFermentationGastrointestinal MicrobiomeHumansInsulin ResistanceMaleMetabolic SyndromeMiddle AgedObesity, MorbidProof of Concept StudyDietary Fiber

Identifiers

PMID34226737
OpenAlexW3182371690

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.