The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment (NCT06681246) | Clinical Trial Compass
RecruitingNot Applicable
The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment
Israel200 participantsStarted 2024-12-11
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.