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Phase 2 Completed N=29 Randomized Quadruple-blind Treatment

Stool Transplantation for Treatment of Insulin Resistance in Morbidly Obese Patients

Obesity, Morbid · Insulin Resistance
Source: ClinicalTrials.gov NCT02970877 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Change in Insulin Resistance Compared to Baseline — -0.25; 1.16; -0.04; 0.93 Index

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Insulin Resistance Compared to Baseline
-0.25; 1.16; -0.04; 0.93
SECONDARY
Weight
126.8; 122.8; 123.8; 122.0; 125.8; 126.4
SECONDARY
Body Mass Index
43.0; 45.1; 43.2; 44.8; 42.64; 44.91
SECONDARY
Appetite Score
7.3; 6.1; 4.9; 3.9; 5.5; 5.5
SECONDARY
Quality of Life Questionnaire
43; 50; 55; 45; 78; 76
SECONDARY
Depression Score
5; 9; 0; 12
SECONDARY
Anxiety Score
4; 7; 1; 10

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02970877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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