About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
28 < BMI< 40
Age - 18-65
Capable of working with a smartphone application
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Antibiotic treatment
Other intervention10 days of either antibiotics- Augmentin (amoxicillin+clauvonate), 875mg, 2 /day
Placebo
Other interventionconsist of a combination of agarose in normal saline/glycerol
Treatment groups
Trial outcomes
Primary outcomes
microbiome composition
using stool and oral samples
weight
weight (kg)
Secondary outcomes
glycemic response
continues glucose monitor (CGM)
Sponsors and contacts
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Weizmann Institute of Science
Lead sponsor
Hadassah Medical Organization
Collaborator