The Role of Microbiome in Recurrent Obesity

Obesity Clinical Trial

Official title:

The Role of Microbiome in Recurrent Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04697550
• Other study ID #: 0215-19-ASF
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2022
• Source: Weizmann Institute of Science
• Contact: aurelie Bukimer mimran
• Phone: +97289529089
• Email: aurelie.bukimer[@]weizmann.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This past century witnessed a significant increase in the prevalence of obesity. successful maintenance of weight loss is defined as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping the low body weight is rarely maintained, as 80% of people who lost 10% of their body weight will return to their initial weight within a year. Although there is no agreement as to what contributes to the recurrent weight regain phenomenon (also known as 'weight cycling' or 'yo-yo diet'), it is strongly associated with the risk of developing metabolic risk factors and their complications including heart disease and all-cause mortality. Altering the gut microbiota is one method to treat disease states associated with gut bacteria. For instance, fecal microbiota transplant (FMT) or fecal bacteriotherapy, is the process of transferring stool from a healthy donor to another. Although numerous individual microbes have been identified as related to obesity, multiple studies suggest that loss of microbial diversity has a stronger impact on the development of metabolic dysfunction, this diversity may be restored by FMT. This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans and whether orally administered FMT from a lean donor, post weight loss might be an effective intervention to prevent weight regain.

Description:

This is a placebo-controlled, double blinded interventional study evaluating high intensity oral fecal microbiota transplantation from lean healthy donors to prevent weight regain after a successful weight loss intervention. Volunteers will be recruited in the following ways: e-mail, and social media. Volunteers wishing to participate will be asked to complete a questionnaire regarding the aforementioned inclusion and exclusion criteria. Volunteers who qualify for the study will be invited to an introductory meeting at the Weizmann Institute of Science. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the volunteers will sign informed consent forms. Volunteers will start the study and become active participants for a maximal duration of two years, depending on the weight loss process

The study will comprise of four parts:

1. Baseline - one week of profiling and screening.

2. Nutritional intervention - weight loss intervention which will be based on Mediterranean hypocaloric diet restriction. Meetings will occur every two weeks starting from the second week of the study.

3. FMT/ Placebo intervention - 5 weekly cycles of high intensity lean donor FMT/placebo will be administered starting after reaching a weight loss of 5 to 10% of total body weight. Each cycle will consist of 10 capsules administered on two consecutive days (total 100 capsules)

4. Follow-up meetings - total follow up of one year after FMT cycles. Meetings will occur every month for the first 3 months of the study, and every 3 months, Afterwards.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 28<BMI>35

• Age - 18-65

• Capable of working with a smartphone application

Exclusion Criteria:

• Consumption of antibiotics/probiotics/oral antifungals 3 months prior to the first day of the experiment.

• Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.

• Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism/hypothyroidism etc.)

• Cancer and recent anticancer treatment

• Psychiatric disorders

• Coagulation disorders

• IBD (inflammatory bowel diseases)

• Bariatric surgery

• Eating disorders (Anorexia nervosa. Bulimia nervosa. Binge eating disorder, Night eating syndrome).

• Alcohol or substance abuse

• Weight loss attempts one year prior to the first day of the experiment - independent or with a dietitian.

Related Conditions & MeSH terms

• FMT
• Obesity
• Weight Loss

Intervention

Other:
• Fecal microbiome transplant
fecal bacteriotherapy is the process of transferring stool from a healthy donor to another.
• placebo
consist of a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eran Elinav	Assaf-Harofeh Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiome composition	using stool, oral and urine samples	1.5 years
Primary	weight	weight (kg)	1.5 years
Secondary	glycemic response	continues glucose monitor (CGM)	1.5 years