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Stool Transplantation for Treatment of Insulin Resistance in Morbidly Obese Patients

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ClinicalTrials.gov Identifier: NCT02970877
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Mount Sinai Hospital, New York
University of Toronto
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Insulin Resistance Biological: Fecal filtrate from 150 g stool from healthy lean donors Biological: Fecal filtrate from 150 g of the recipient's own stool Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplant From Healthy Lean Donors to Morbidly Obese Individuals: Effect on Insulin Resistance and Other Obesity-related Parameters. A Randomized Controlled Trial.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Allogenic treatment group
Fecal filtrate from 150 g stool from healthy lean donors
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.
Other Name: Intestinal microbiota from healthy lean donors

Placebo Comparator: Autologous control group
Fecal filtrate from 150 g of the recipient's own 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.
Other Name: Autologous intestinal microbiota




Primary Outcome Measures :
  1. Change in Insulin Resistance compared to baseline [ Time Frame: 1 month, 3 month ]
    Homeostasis model of assessment for insulin resistance (HOMA-IR)


Secondary Outcome Measures :
  1. Weight [ Time Frame: Baseline, 1 mo, 3 mo ]
    Body weight (kg)

  2. Body mass index [ Time Frame: Baseline, 1 mo, 3 mo ]
    Weight (kg) / height (m)²

  3. Percentage weight change compared to baseline [ Time Frame: 1 mo, 3 mo ]
    % weight change compared to baseline

  4. Appetite score [ Time Frame: Baseline, 1 mo, 3 mo ]
    Appetite score according to rating scale

  5. Quality of Life [ Time Frame: Baseline, 3 mo ]
    RAND 36-Item Health Survey 1.0 (SF-36)

  6. Depression score [ Time Frame: Baseline, 3 mo ]
    Montgomery-Åsberg Depression Rating Scale (MADRS)

  7. Anxiety score [ Time Frame: Baseline, 3 mo ]
    Hamilton Anxiety Rating Scale (Ham-A)


Other Outcome Measures:
  1. Hemoglobin A1c [ Time Frame: Baseline, 1 mo, 3 mo ]
  2. C-reactive protein [ Time Frame: Baseline, 1 mo, 3 mo ]
  3. HOMA-B% [ Time Frame: Baseline, 1 mo, 3 mo ]
    HOMA steady state beta cell function (%B)

  4. Intestinal microbiome in stool, composition [ Time Frame: Baseline, 1 mo, 3 mo ]
    Measured by 16S sequencing

  5. Intestinal microbiome in stool, function [ Time Frame: Baseline, 1 mo, 3 mo ]
    Metagenome sequencing

  6. Intestinal microbiome in stool, quantitative [ Time Frame: Baseline, 1 mo, 3 mo ]
    Quantitative real-time polymerase chain reaction (qPCR)

  7. Blood lipid profile [ Time Frame: Baseline, 1 mo, 3 mo ]
  8. Physical examination performed by the physician [ Time Frame: Baseline, 3 mo ]
    All major signs will be checked to see if apparatus are normal or if abnormal findings are present (Head, Ears, Eyes, Nose, Throat, Neck, Lungs, Heart, Abdomen, Skin, Neurological, Anal, Gynecological).

  9. Change in food intake [ Time Frame: Baseline, 1 mo, 3 mo ]
    Total daily energy intake from 3-day food records

  10. Change in food intake [ Time Frame: Baseline, 1 mo, 3 mo ]
    Daily fat intake (amount g/d, energy and % of energy) from 3-day food records

  11. Change in food intake [ Time Frame: Baseline, 1 mo, 3 mo ]
    Daily carbohydrates intake (amount g/d, energy and % of energy) from 3-day food records

  12. Change in food intake [ Time Frame: Baseline, 1 mo, 3 mo ]
    Daily protein intake (amount g/d, energy and % of energy) from 3-day food records

  13. Change in food intake [ Time Frame: Baseline, 1 mo, 3 mo ]
    Daily fiber intake (amount g/d, energy and % of energy) from 3-day food records

  14. Physical activity [ Time Frame: Baseline, 1 mo, 3 mo ]
    Activity log, self-completed

  15. Environmental questionnaire [ Time Frame: Baseline, 1 mo, 3 mo ]
    Questionnaire assessing environmental factors that may influence the intestinal microbiome

  16. Stool metabolomics [ Time Frame: Baseline, 1 mo, 3 mo ]
    Nuclear magnetic resonance spectroscopy

  17. Serum metabolomics [ Time Frame: Baseline, 1 mo, 3 mo ]
    Nuclear magnetic resonance spectroscopy

  18. Oral microbiome [ Time Frame: Baseline, 3 mo ]
    16S sequencing, metagenome, quantification by qPCR

  19. Dental questionnaire [ Time Frame: Baseline, 3 mo ]
    Questionnaire assessing oral health and hygiene

  20. Mucosa-associated microbiome [ Time Frame: Baseline ]
    Mucosa from intestinal pinch biopsies, taken during colonoscopy 16S sequencing, metagenome, qPCR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970877


Contacts
Contact: Monica L Ponta, MD +1 416-340-4413 monica.ponta@uhnresearch.ca
Contact: Johane P Allard, MD +1 416-340-5159 johane.allard@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Monica L Ponta, MD    416-340-4413    monica.ponta@uhnresearch.ca   
Contact: Johane P Allard, MD    416-340-5159    johane.allard@uhn.on.ca   
Principal Investigator: Johane P Allard, MD         
Sponsors and Collaborators
Johane Allard
Canadian Institutes of Health Research (CIHR)
Mount Sinai Hospital, New York
University of Toronto
Investigators
Principal Investigator: Johane P Allard, MD University Health Network, University of Toronto

Publications:
Responsible Party: Johane Allard, Gastroenterologist, Senior Researcher, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02970877     History of Changes
Other Study ID Numbers: 16-5475
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The current data sharing plans for the current study are unknown and will be made available at a later date

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johane Allard, University Health Network, Toronto:
Fecal microbiota transplant
Intestinal microbiome
Oral microbiome
Mucosa associated microbiome
Appetite
Metabolome
Depression
Anxiety

Additional relevant MeSH terms:
Nutrition Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Obesity
Insulin Resistance
Obesity, Morbid
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism