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NCT02741518: FMT Obesity

Fecal Microbiota Transplantation for the Treatment of Obesity

Completed Phase 1, PHASE2 Results posted Last updated 7 January 2020
What this trial tests

Phase 1, PHASE2 trial testing Fecal Microbiota Transplantation in Obesity in 22 participants. Completed in 24 July 2019.

Timeline
1 April 2017
Primary endpoint
18 October 2018
24 July 2019

Quick facts

Lead sponsorBrigham and Women's Hospital
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment22
Start date1 April 2017
Primary completion18 October 2018
Estimated completion24 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adverse Event Frequency Primary · 6 months

Number of patients reporting adverse events

Patients experiencing AEs
GroupValue95% CI
Treatment Arm11
Placebo Arm11
Patients who Experienced SAE
GroupValue95% CI
Treatment Arm1
Placebo Arm0
Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12 Secondary · 12 weeks

Fecal Microbiota Transplantation will lead to an increase in short chain fatty acids which will lead to an increase in the metabolic regulator GLP-1

GroupValue95% CI
Treatment Arm509.6± 318.7
Placebo Arm311.3± 261

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over the course 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm
Serious: 1/11 (9%)
Deaths: 0/11
Placebo Arm
Serious: 0/11 (0%)
Deaths: 0/11

Serious adverse events (1 terms)

ReactionSystemTreatment ArmPlacebo Arm
ER Visit for Vomiting and DiarrheaGastrointestinal disorders
Other adverse events (15 terms — click to expand)

ReactionSystemTreatment ArmPlacebo Arm
Abdominal PainGastrointestinal disorders
DiarrheaGastrointestinal disorders
BloatingGastrointestinal disorders
NauseaGeneral disorders
ConstipationGastrointestinal disorders
GasGastrointestinal disorders
HeadacheNervous system disorders
FeverGeneral disorders
Blood in stoolGastrointestinal disorders
HeartburnGastrointestinal disorders
Insect BiteGeneral disorders
BruisesGeneral disorders
Sinus infectionRespiratory, thoracic and mediastinal disorders
VomitingGeneral disorders
Back PainMusculoskeletal and connective tissue disorders

Most-reported serious reactions: ER Visit for Vomiting and Diarrhea.

Data from ClinicalTrials.gov NCT02741518 adverse events section.

Sponsor's own description

This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of Fecal Microbiota Transplantation With Oral Capsules in Obese Patients.
    Allegretti JR, Kassam Z, Mullish BH, Chiang A, et al · · 2020 · cited 222× · PMID 31301451 · DOI 10.1016/j.cgh.2019.07.006
  2. Gut liver brain axis in diseases: the implications for therapeutic interventions.
    Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4
  3. Fecal microbiota transplantation beyond Clostridioides difficile infections.
    Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
  4. Role of the intestinal microbiome and its therapeutic intervention in cardiovascular disorder.
    Luqman A, Hassan A, Ullah M, Naseem S, et al · · 2024 · cited 76× · PMID 38343539 · DOI 10.3389/fimmu.2024.1321395
  5. The role of the gut microbiota in health and cardiovascular diseases.
    Wang L, Wang S, Zhang Q, He C, et al · · 2022 · cited 70× · PMID 36219347 · DOI 10.1186/s43556-022-00091-2
  6. Diversity of the Gut Microbiota in Dihydrotestosterone-Induced PCOS Rats and the Pharmacologic Effects of Diane-35, Probiotics, and Berberine.
    Zhang F, Ma T, Cui P, Tamadon A, et al · · 2019 · cited 62× · PMID 30800111 · DOI 10.3389/fmicb.2019.00175
  7. Impact of Fecal Microbiota Transplantation on Gut Bacterial Bile Acid Metabolism in Humans.
    Bustamante JM, Dawson T, Loeffler C, Marfori Z, et al · · 2022 · cited 45× · PMID 36558359 · DOI 10.3390/nu14245200
  8. Gut Microbiota in Liver Disease: What Do We Know and What Do We Not Know?
    Jiang L, Schnabl B. · · 2020 · cited 44× · PMID 32490750 · DOI 10.1152/physiol.00005.2020

Verify or expand the search:

Other trials of Fecal Microbiota Transplantation

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02741518.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing