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The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment

The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06681246
Enrollment
200
Registered
2024-11-08
Start date
2024-12-11
Completion date
2027-12-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Weight Loss

Brief summary

This past century witnessed a significant increase in the prevalence of obesity. Successful weight loss maintenance is defined as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping a 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. Antibiotics consumption is known to influence host glycemic response through changes induced in microbiome composition and function. Therefore, it may be a possible pathway to jumpstart changes in the gut microbiota. This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans and whether orally administered antibiotic treatment post-weight loss might be an effective intervention to prevent weight regain.

Detailed description

This is a placebo-controlled, double blinded interventional study evaluating the effect of antibiotic treatment in the prevention of 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 an informed consent form. Volunteers will start the study and become active participants for a maximal duration of one year. Samples collected for the study will be used for microbiota profiling (stool and oral), metabolomics (stool, blood) and for bomb calorimeter (stool). 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 personalized hypocaloric diet restriction. Meetings will occur twice a month starting from the second week of the study for a three-month period. 3. Antibiotic treatment - 10 days of either antibiotics- Augmentin (amoxicillin+clauvonate), 875mg, 2 /day, or 10 days of placebo pills, 2/day. 4. Follow-up meetings - total follow up of 9 months after antibiotic/placebo treatment. Meetings will occur once a month for the first 3 months of the follow up period, and once every 3 months, afterwards.

Interventions

10 days of either antibiotics- Augmentin (amoxicillin+clauvonate), 875mg, 2 /day

OTHERPlacebo

consist of a combination of agarose in normal saline/glycerol

Sponsors

Weizmann Institute of Science
Lead SponsorOTHER
Hadassah Medical Organization
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 28\<BMI\<35 * Age - 18-65 * Capable of working with a smartphone application

Exclusion criteria

* Consumption of antibiotics/probiotics/oral antifungals 2 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, to the discretion of the study team (e.g. AIDS, Cushing syndrome, CKD, acromegaly etc.) * Cancer and recent anticancer treatment * Psychiatric disorders, to the discretion of the study team. * 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 6 months prior to the first day of the experiment - using weight loss medication. * Drastic changes in nutritional habits six months prior to the first day of the study - to the discretion of the study team. * Allergy to penicillin. * Life threatening reaction after consumption of cephalosporins. * History of CDI * Liver disease * History of serious unresolved diarrhea in response to antibiotic treatment to the discretion of the study doctor.

Design outcomes

Primary

MeasureTime frameDescription
microbiome composition1 yearusing stool and oral samples
weight1 yearweight (kg)

Secondary

MeasureTime frameDescription
glycemic response1 yearcontinues glucose monitor (CGM)

Countries

Israel

Contacts

CONTACTEran Elinav, Professor
Eran.Elinav@weizmann.ac.il+97289349174
CONTACTBarbara Raykhel
barbara.raykhel@weizmann.ac.il+97289346590
PRINCIPAL_INVESTIGATORHila Elinav, Doctor

Hadassah Medical Organization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026