The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment
Recruiting · NCT06681246 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 28 \< BMI\< 40
- 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 it is running
1 location listed.
- Weizmann Institute of Science - Rehovot, Israel