Fecal filtrate from 150 g stool from healthy lean donors for Obesity, Morbid

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Obesity, Morbid+2 More
Fecal filtrate from 150 g stool from healthy lean donors - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a treatment that transfers stool from healthy people into obese people can improve blood sugar control and weight.

Eligible Conditions
  • Obesity, Morbid
  • Insulin Resistance

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1 month, 3 month

1 mo, 3 mo
Percentage weight change compared to baseline
1 month, 3 month
Change in Insulin Resistance compared to baseline
Baseline
Mucosa-associated microbiome
Baseline, 1 mo, 3 mo
Appetite score
Blood lipid profile
Body mass index
C-reactive protein
Change in food intake
Environmental questionnaire
Boron
Hemoglobin A1c
Intestinal microbiome in stool, composition
Intestinal microbiome in stool, function
Intestinal microbiome in stool, quantitative
Physical activity
Serum metabolomics
Stool metabolomics
Weight
Baseline, 3 mo
Anxiety score
Dental questionnaire
Depression score
Oral microbiome
Physical examination performed by the physician
Quality of Life Questionnaire

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Allogenic treatment group
1 of 2
Autologous control group
1 of 2

Experimental Treatment

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Fecal filtrate from 150 g stool from healthy lean donors · Has Placebo Group · Phase 2

Allogenic treatment group
Biological
Experimental Group · 1 Intervention: Fecal filtrate from 150 g stool from healthy lean donors · Intervention Types: Biological
Autologous control group
Biological
PlaceboComparator Group · 1 Intervention: Fecal filtrate from 150 g of the recipient's own stool · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month, 3 month

Who is running the clinical trial?

Johane AllardLead Sponsor
9 Previous Clinical Trials
887 Total Patients Enrolled
1 Trials studying Obesity, Morbid
120 Patients Enrolled for Obesity, Morbid
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,223 Previous Clinical Trials
24,403,685 Total Patients Enrolled
1 Trials studying Obesity, Morbid
120 Patients Enrolled for Obesity, Morbid
University of TorontoOTHER
624 Previous Clinical Trials
718,905 Total Patients Enrolled
MOUNT SINAI HOSPITALOTHER
35 Previous Clinical Trials
12,339 Total Patients Enrolled
Johane P Allard, MDPrincipal InvestigatorUniversity Health Network, University of Toronto

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.