NCT02741518

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Apr 2017

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

April 12, 2016

Results QC Date

December 3, 2019

Last Update Submit

December 19, 2019

Conditions

Obesity

Keywords

obesityFMT

Outcome Measures

Primary Outcomes (1)

  • Adverse Event Frequency

    Number of patients reporting adverse events

    6 months

Secondary Outcomes (1)

  • Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12

    12 weeks

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

The treatment arm will receive an induction dose of FMT via capsules (30) followed by monthly maintenance oral capsules(12) at week 4 and week 8. Donor Stool from healthy lean donors and placebo material will be obtained from OpenBiome. OpenBiome, is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use

Biological: Fecal Microbiota Transplantation

Placebo Arm

PLACEBO COMPARATOR

The placebo group will receive a placebo FMT capsules at the time of their screening colonoscopy followed by monthly intake of oral placebo capsules at week 4 and week 8

Other: Placebo

Interventions

Fecal Microbiota TransplantationBIOLOGICAL

This is pre-screened fecal material that has been encapsulated

Also known as: FMT
Treatment Arm
PlaceboOTHER

These are capsules that have no fecal material in them.

Placebo Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Obesity defined as a BMI of 35kg/m2 or higher

You may not qualify if:

  • Triglycerides \> 500 mg/dL
  • Use of antibiotics \<8 weeks prior to participation
  • Use of probiotics \<4 weeks prior to participation
  • Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence
  • Substance abuse, current
  • LFTS greater then 3x the ULN
  • Cirrhosis.
  • DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C \> 10%)
  • Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers
  • History of recent weight change (weight loss or weight gain in the two months preceding trial enrollment). This is defined as a gain or loss of 10 or more pounds in the preceding 2 months
  • Patients who are pregnant or breastfeeding
  • Patients who are unable to give informed consent
  • \. Patients who have previously undergone FMT 15. Patients who have a confirmed malignancy or cancer 16. Patients who are immunocompromised 17. Participation in a clinical trial in the preceding 30 days or simultaneously during this trial 18. Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileocectomy 19. Other comorbidities including: systemic lupus, inflammatory bowel disease, or Chronic kidney disease as defined by a GFR \<60mL/min/1.73m2 44 20. History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia 21. Any condition, based on clinical judgment that may make study participation unsafe 22. History of severe food allergies 23. Use of immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11 24.Treatment with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide 25. Congenital or acquired immunodeficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Allegretti JR, Kassam Z, Hurtado J, Marchesi JR, Mullish BH, Chiang A, Thompson CC, Cummings BP. Impact of fecal microbiota transplantation with capsules on the prevention of metabolic syndrome among patients with obesity. Hormones (Athens). 2021 Mar;20(1):209-211. doi: 10.1007/s42000-020-00265-z. Epub 2021 Jan 9.

    PMID: 33420959DERIVED

  • Allegretti JR, Kassam Z, Mullish BH, Chiang A, Carrellas M, Hurtado J, Marchesi JR, McDonald JAK, Pechlivanis A, Barker GF, Miguens Blanco J, Garcia-Perez I, Wong WF, Gerardin Y, Silverstein M, Kennedy K, Thompson C. Effects of Fecal Microbiota Transplantation With Oral Capsules in Obese Patients. Clin Gastroenterol Hepatol. 2020 Apr;18(4):855-863.e2. doi: 10.1016/j.cgh.2019.07.006. Epub 2019 Jul 10.

    PMID: 31301451DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Results Point of Contact

Title
Dr. Jessica Allegretti
Organization
Brigham and Women's Hospital
jallegretti@bwh.harvard.edu
617-732-5500

Study Officials

  • Christopher C Thompson, MD, MSC

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Jessica R Allegretti, MD, MPH

    Brigham and Women's Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 18, 2016

Study Start

April 1, 2017

Primary Completion

October 18, 2018

Study Completion

July 24, 2019

Last Updated

January 7, 2020

Results First Posted

January 7, 2020

Record last verified: 2019-12

Locations

US(1)