Probiotic Support for GLP-1 RA Weight Loss in Obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates whether adding probiotics to GLP-1 RA therapy (semaglutide or tirzepatide) for obesity improves gastrointestinal tolerability and potentially enhances weight loss. Participants are adults with obesity who are about to begin a GLP-1 RA and will be randomized to receive either probiotics or placebo alongside standard therapy. The trial uses standard clinical procedures and self-rated scales to monitor side effects, adherence, and quality of life over the treatment period. It builds on evidence that probiotics can improve gut health and reduce GI symptoms, with the aim of reducing GLP-1 RA-related GI adverse events and supporting better treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient who is going to start a GLP-1 RA (semaglutide or tirzepatide) for weight management
* Men or Women
* BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 associated with one or more co-morbidities (arterial hypertension, sleep apnea, dyslipidemia, arthritis)
* Between 18 and 75 years old
* In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, ability to understand and fill the self-rating scales, drug compliance, availability to attend to the scheduled visits, etc…).
* Patient who agrees to be included in the study and who signs the informed consent form
* Female participants of childbearing potential must agree to use effective contraception
* Patient affiliated to a healthcare insurance plan

Exclusion Criteria:

Criteria relating to the study population:

* Patients under 18 years old
* Patient with contraindication to semaglutide or tirzepatide according to the Summary of Product Characteristics (SPC).
* Patients scheduled for bariatric surgery during the study period
* Patients who have had bariatric surgery in the last 12 months
* Patient with a current diagnosis of diabetes.
* Patients with a current diagnosis of liver cirrhosis, short bowel syndrome or inflammatory bowel disease (IBD).
* Patients with severely weakened immune system.
* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.

Product criteria:

Patient with known allergy to the product of the study

Prohibited treatments :

Current associated treatments or used in the last 30 days: GLP-1 RA, Anti-obesity drugs (AOD), Corticosteroids, Atypical neuroleptics, Antibiotics, Probiotics, Prebiotics

Regulatory criteria :

* Persons deprived of their liberty by a judicial or administrative decision
* Persons under psychiatric care
* Persons admitted to a health or social institution for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
* Subjects participating in other interventional research with an exclusion period still in progress at pre-inclusion

Where it's running

• Hôpital Lyon Sud
  Pierre-Bénite, France Recruiting

Study contacts

• Principal investigator: Emmanuel DISSE, PUPH — Hospices Civils de Lyon
• Study coordinator: Emmanuel DISSE, PUPH
• Email: Emmanuel.disse@chu-lyon.fr
• Phone: +33478861484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.