Last updated August 24, 2026
Key finding
Mean difference 9%, 95% CI −5% to 28%, p = 0.16
This pilot trial investigated the safety and metabolic effects of fecal microbiota transplantation (FMT) capsules in adults with obesity and insulin resistance, finding no significant improvements compared to placebo.
Quick read
The essential study design details in one scan.
EvidenceScore™
Moderate
Study type
RCTs
Follow-up
Medium-Term (3–12 mo)
Risk of bias
Some Concerns
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Plain-language summary
A plain-language read of the study’s main message and where it applies.
Study focus
This pilot trial investigated the safety and metabolic effects of fecal microbiota transplantation (FMT) capsules in adults with obesity and insulin resistance, finding no significant improvements compared to placebo.
Understanding the effects of FMT on metabolic health is crucial, especially for managing obesity and insulin resistance. This study suggests that FMT capsules may not provide the expected metabolic improvements, which is important for clinicians considering this treatment for their patients.
Small sample size may limit generalizability. Short duration of the intervention may not capture long-term effects. Lack of diversity in the participant population could affect applicability.
Published in
Publication details and source links for this paper.
Elaine WY, Liu G, Petr S, et al. Safety and Metabolic Effects of Fecal Microbiota Transplantation Capsules in Adults with Obesity and Insulin Resistance: A Pilot Trial. PLOS Medicine. 2020;17(3):e1003051. doi:10.1371/journal.pmed.1003051
Insulin sensitivity showed no significant improvement in the FMT group (+5% ± 12%) compared to placebo (−3% ± 32%), p = 0.16.
No significant differences in insulin resistance (HOMA-IR) between groups (mean difference 0.2, p = 0.96).
Body composition analysis revealed no significant changes in lean mass (mean difference −0.1 kg, p = 0.87) or fat mass (mean difference 1.2 kg, p = 0.18).
Evidence network
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This study contributes evidence to Healthy lean-donor fecal microbiota transplantation capsules and Adverse events incidence, Body fat mass, Insulin resistance, and 1 more.
This study contributes evidence to
Primary intervention
Healthy lean-donor fecal microbiota transplantation capsules
Primary outcomes
Evidence topics
Primary intervention
Primary outcomes
Intervention and outcome relationships this study adds to the evidence network.
Editorial context
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Evidence network role
This section describes how the study fits into the current evidence network. It does not determine whether an intervention works on its own.
2
Related topics
4
Evidence pairs
451
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Contributes evidence
Evidence topic
Contributes evidence
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Primary evidence
Evidence topic
matched_outcome
Related evidence
Evidence topic
Save evidence
Core evidence
The primary outcomes reported in this study.
Healthy lean-donor fecal microbiota transplantation capsules → Adverse events incidence
Healthy lean-donor fecal microbiota transplantation capsules → Adverse events incidence
Healthy lean-donor fecal microbiota transplantation capsules → Body fat mass
Healthy lean-donor fecal microbiota transplantation capsules → Body fat mass
Healthy lean-donor fecal microbiota transplantation capsules → Insulin resistance
Healthy lean-donor fecal microbiota transplantation capsules → Insulin resistance
Healthy lean-donor fecal microbiota transplantation capsules → Insulin sensitivity
Healthy lean-donor fecal microbiota transplantation capsules → Insulin sensitivity
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Relationships organized using the Dediabetes Evidence Intelligence™ framework.
This study contributes to evidence on Healthy lean-donor fecal microbiota transplantation capsules and Adverse events incidence, Healthy lean-donor fecal microbiota transplantation capsules and Body Composition.
This study contributes to the evidence on the following intervention-outcome relationships.
Curated evidence collections and hubs this study is part of.
All studies measuring Adverse events incidence
Measures Adverse events incidence as a key outcome.
All studies measuring Body Composition
Measures Body Composition as a key outcome.
All studies on Healthy lean-donor fecal microbiota transplantation capsules
Contributes to Healthy lean-donor fecal microbiota transplantation capsules evidence base.
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1 results
1 results
1 results
1 results
1 results
Generated from the study's connected evidence using Evidence Intelligence™.
Current evidence does not show a clear reduction in adverse events incidence with Healthy lean-donor fecal microbiota transplantation capsules.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Adverse events incidence
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Current evidence does not show a clear benefit of Healthy lean-donor fecal microbiota transplantation capsules for body fat mass.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Body fat mass
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Current evidence does not show a clear benefit of Healthy lean-donor fecal microbiota transplantation capsules for insulin resistance.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Insulin resistance
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
Current evidence does not show a clear benefit of Healthy lean-donor fecal microbiota transplantation capsules for insulin sensitivity.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
Insulin sensitivity
EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study
Why this answer: This answer is based on a single supporting study.
Limitations
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