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

NCT06681246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Antibiotic treatment

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

OTHER

Placebo

consist of a combination of agarose in normal saline/glycerol

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Weizmann Institute of Science

    lead OTHER

Principal Investigators

  • Hila Elinav, Doctor · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681246 on ClinicalTrials.gov