NCT06681246 The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment
| NCT ID | NCT06681246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weizmann Institute of Science |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-12-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Hila Elinav, Doctor
PRINCIPAL INVESTIGATOR
Hadassah Medical Organization
Frequently Asked Questions
Who can join the NCT06681246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06681246 currently recruiting?
Yes, NCT06681246 is actively recruiting participants. Contact the research team at Eran.Elinav@weizmann.ac.il for enrollment information.
Where is the NCT06681246 trial being conducted?
This trial is being conducted at Rehovot, Israel.
Who is sponsoring the NCT06681246 clinical trial?
NCT06681246 is sponsored by Weizmann Institute of Science. The principal investigator is Hila Elinav, Doctor at Hadassah Medical Organization. The trial plans to enroll 200 participants.
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