Exploring how gut bacteria affect weight regain after losing weight
The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment
NA · Weizmann Institute of Science · NCT06681246
This study tests whether taking antibiotics after losing weight can help people keep the weight off by looking at how gut bacteria play a role in weight maintenance.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Weizmann Institute of Science (other) |
| Locations | 1 site (Rehovot) |
| Trial ID | NCT06681246 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the impact of antibiotic treatment on preventing weight regain in individuals who have successfully lost weight. Participants will undergo a personalized hypocaloric diet followed by a 10-day course of either antibiotics or a placebo. The study includes microbiota profiling and metabolomics assessments to understand the relationship between gut bacteria and weight maintenance. Participants will be monitored for a total of one year, with follow-up meetings to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI between 28 and 35 who are capable of using a smartphone application.
Not a fit: Patients with chronic diseases, recent cancer treatment, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to help individuals maintain weight loss and reduce the risk of obesity-related health complications.
How similar studies have performed: While the role of the microbiome in obesity is being explored, this specific approach using antibiotics for weight maintenance is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rehovot
- Weizmann Institute of Science — Rehovot, Israel (RECRUITING)
Study contacts
- Principal investigator: Hila Elinav, Doctor — Hadassah Medical Organization
- Study coordinator: Eran Elinav, Professor
- Email: Eran.Elinav@weizmann.ac.il
- Phone: +97289349174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Weight Loss