Stool Transplantation for Treatment of Insulin Resistance in Morbidly Obese Patients

NCT02970877 | Completed Phase 2 Results DMC

• 1 other identifier: 16-5475
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Obesity, Morbid; Insulin Resistance

Keywords

Fecal microbiota transplant; Intestinal microbiome; Mucosa associated microbiome; Appetite; Metabolome; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance Compared to Baseline

  Looking at the change in Homeostasis model of assessment for insulin resistance (HOMA-IR). HOMA-IR \> 2.73 is considered as insulin resistance. The higher HOMA-IR, the worse the insulin resistance. For this measure, we looked at the change in HOMA-IR. Those with more reduction in HOMA-IR experience more improvement in their insulin resistance.

  1 month, 3 month

Secondary Outcomes (6)

• Weight

  Baseline, 1 mo, 3 mo

• Body Mass Index

  Baseline, 1 mo, 3 mo

• Appetite Score

  Baseline, 1 mo, 3 mo

• Quality of Life Questionnaire

  Baseline, 3 mo

• Depression Score

  Baseline, 3 mo

Other Outcomes (11)

• Hemoglobin A1c

  Baseline, 1 mo, 3 mo

• Change in Intestinal Microbiome in Stool, Composition

  Baseline, 1 mo, 3 mo

• Blood Lipid Profile

  Baseline, 1 mo, 3 mo

Study Arms (2)

Allogenic treatment group

EXPERIMENTAL

Fecal filtrate from 150 g stool from healthy lean donors

Biological: Fecal filtrate from 150 g stool from healthy lean donors

Autologous control group

PLACEBO COMPARATOR

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

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

Interventions

Fecal filtrate from 150 g stool from healthy lean donors BIOLOGICAL

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.

Also known as: Intestinal microbiota from healthy lean donors

Allogenic treatment group

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

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.

Also known as: Autologous intestinal microbiota

Autologous control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• age 18 years or older
• morbidly obese (BMI \>40 kg/m² or BMI \>35-40 kg/m² with other severe weight loss responsive comorbidities)
• referred to the Bariatric Clinic at the Toronto Western Hospital for weight loss surgery, but declining or deferring the surgery
• insulin resistance (HOMA-IR value \>2.73)

You may not qualify if:

• In the 3 months prior to study entry, regular intake of:
• non-steroidal anti-inflammatory drugs;
• iron supplements;
• prebiotics or probiotics from other than food sources;
• antibiotics; or
• any experimental drug
• Type 1 or type 2 diabetes
• chronic gastrointestinal diseases
• previous gastrointestinal surgery modifying the anatomy
• smoking
• pregnancy or breastfeeding

Sponsors & Collaborators

• Johane Allard: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• MOUNT SINAI HOSPITAL: collaborator
• University of Toronto: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

• Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20.

  PMID: 22728514 BACKGROUND

• Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.

  PMID: 25982290 BACKGROUND

• Hamilton MJ, Weingarden AR, Unno T, Khoruts A, Sadowsky MJ. High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. Gut Microbes. 2013 Mar-Apr;4(2):125-35. doi: 10.4161/gmic.23571. Epub 2013 Jan 18.

  PMID: 23333862 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Insulin Resistance; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Scientific Associate
• Organization: University Health Network

kschweng@uhnresearch.ca

416-340-5159

Study Officials

• Johane P Allard, MD

  University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastroenterologist, Senior Researcher

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: November 22, 2016
• Study Start: March 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)