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Stool Transplantation for Treatment of Insulin Resistance in Morbidly Obese Patients

NCT02970877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-04-24

Study results available
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Summary

More and more people in Canada and around the world are severely (morbidly) obese, and this is associated with a high risk for poor blood sugar control (insulin resistance, IR) and diabetes. Weight loss is often very hard to achieve for morbidly obese patients. Bariatric surgery is a very effective treatment, but it has some risks and is not available to all patients. Therefore, alternative treatments are needed.

The gut bacteria (intestinal microbiome) might play a role for the development of obesity and IR. Several studies in animals have shown that transferring stool from lean mice or humans into obese animals could lead to weight loss and improve IR. One human study has confirmed this. The investigators are therefore examining, whether transfer of stool from healthy lean people into morbidly obese patients with IR will improve blood sugar control, weight, and other obesity related parameters. This will be done in a randomized controlled trial. Effects on mental health and the bacterial in the mouth related to gum disease will also be assessed.

If successful, fecal transfer could be a new alternative treatment approach for morbidly obese patients or those with IR who do not have access to or do not want to undergo bariatric surgery.

Conditions

Interventions

BIOLOGICAL

Fecal filtrate from 150 g stool from healthy lean donors

150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.

BIOLOGICAL

Fecal filtrate from 150 g of the recipient's own stool

150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Johane Allard

    lead OTHER

Principal Investigators

  • Johane P Allard, MD · University Health Network, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2022-06-30
Completion
2022-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970877 on ClinicalTrials.gov