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Cited by 328Gut microbiota and healthGastrointestinal motility and disordersBariatric Surgery and Outcomes

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

Mocanu, Valentin, Zhang, Zhengxiao, Deehan, Edward C., Kao, Dina H., Hotte, Naomi, Karmali, Shahzeer, Birch, Daniel W., Samarasinghe, Kalutota K. +2 more·2021·Nature Medicine
DOI 10.1038/s41591-021-01399-2
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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…

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  • The high efficacy rate of FMT in rCDI is not observed under other conditions where the characteristics of donors, recipients, and working protocols appear to largely impact clinical outcomes.

    “This concept is supported by evidence that the high efficacy rate of FMT in rCDI is not observed under other conditions where the characteristics of donors, 26,39 recipients, 41,42 and working protocols, 43 appear to largely impact clinical outcomes.”

    From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [43]

  • In a randomized controlled trial of patients with severe obesity and MetS, post-FMT supplementation with LF fibers (microcrystalline cellulose fiber) was more effective than high-fermentable (HF) fibers in promoting microbial engraftment and improving insulin sensitivity.

    “Notably, in a randomized controlled trial of patients with severe obesity and MetS, postFMTsupplementation with LF fibers (specifically microcrystalline cellulose fiber) was more effective than high-fermentable (HF) fibers in promoting microbial engraftment and improving insulin sensitivity.”

    From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [43]

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Authors
Mocanu, V., Zhang, Z., Deehan, E. C., Kao, D. H., Hotte, N., Karmali, S., Birch, D. W., Samarasinghe, K. K., Walter, J., & Madsen, K. L.
Affiliations
  • University of Alberta (CA)
  • University College Cork (IE)
Corresponding author
Madsen, Karen L.
ORCID
Venue
Nature Medicine
Publisher
Springer Science and Business Media LLC
Published
2021-07
Volume
27
Issue
7
Pages
1272-1279
ISSN
  • 1078-8956 (ISSN-L)
  • 1546-170X
DOI
10.1038/s41591-021-01399-2
OpenAlex
W3182371690
Cited by
328
References
55
Citations by year
2026: 51 · 2025: 77 · 2024: 67 · 2023: 56 · 2022: 65 · 2021: 12
FWCI
15.85
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Nature Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Gouvernement du Canada | Canadian Institutes of Health Research
  • University of Alberta Clinical Investigator Program
  • Canadian Institutes for Health Research.
  • The W. Garfield Weston Foundation.
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
Keywords
fecal microbiota transplantation, dietary fiber supplementation, morbid obesity, metabolic syndrome, insulin sensitivity, cardiometabolic outcomes, gut microbiota
MeSH terms
Gastrointestinal Microbiome, Fecal Microbiota Transplantation, Proof of Concept Study, Dietary Fiber, Double-Blind Method, Female, Fermentation, Humans, Insulin Resistance, Male, Middle Aged, Obesity, Morbid, Dietary Supplements, Metabolic Syndrome

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