PROBIO-GLP1

Not yet recruitingPhase NA

Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment

Evaluation of the Efficacy of Probiotics on Digestive Quality of Life in Patients Initiating GLP-1 Receptor Agonists for the Treatment of Obesity. A Randomized, Double-blind Trial

Lead sponsor

Hospices Civils de Lyon

Assets

GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Assessment of the Limitation of the impairment in digestive quality of life

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07213323

Org study ID69HCL25_0321

Secondary ID2025-A01248-41ID-RCB

Timeline

Milestones

Study first posted2025-10-08actual

Last update posted2025-10-08actual

Study start2025-12-15estimated

Primary completion2027-04-15estimated

Study completion2027-12-15estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

6 endpoints

Secondary/protocol endpoint

Weight loss

Time frame:4, 8, 12, 16, 20 and 24 weeks of intervention

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Weight loss

Time frame:4, 8, 12, 16, 20 and 24 weeks of intervention

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Weight loss

Time frame:4, 8, 12, 16, 20 and 24 weeks of intervention

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Fat mass

Time frame:Baseline, before implementation of GLP1-RA, 12 and 24 weeks of treatment

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Lean mass

Time frame:Baseline, before implementation of GLP1-RA, 12 and 24 weeks of treatment

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Skeletal muscle mass

Time frame:Baseline, before implementation of GLP1-RA, 12 and 24 weeks of treatment

Lean mass

change from baseline, improvement

Patient-reported / QoL

9 endpoints

Primary/protocol endpoint

Assessment of the Limitation of the impairment in digestive quality of life during the dose escalation of GLP1-RA (semaglutide or tirzepatide)

Time frame:Every 5 weeks

change from baseline, improvement

Secondary/protocol endpoint

Digestive quality of life

Time frame:From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Nausea

Time frame:From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Dyspepsia

Time frame:From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Diarrhea

Time frame:From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Constipation

Time frame:From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Abdominal pain

Time frame:From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Quality of life assessed with GIQLI questionnaire

Time frame:baseline, 12 and 24 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

Quality of life assessed with SF36 questionnaire

Time frame:baseline, 12 and 24 weeks of treatment

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint/low confidence

GLP-1 receptor agonist dosage

Time frame:4, 8, 12, 16, 20 and 24 weeks of intervention

descriptive

Secondary/protocol endpoint/low confidence

GLP1-RA dose escalation

Time frame:4, 8, 12, 16, 20 and 24 weeks of intervention

threshold achievement, descriptive

Secondary/protocol endpoint

GLP1-RA dose discontinuation/maintenance

Time frame:4, 8, 12, 16, 20 and 24 weeks of intervention

Discontinuation due to AE

threshold achievement, event

Secondary/protocol endpoint

Adverse Events

Time frame:After 4, 8, 12, 16, 20 and 24 weeks of treatment.

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Severe Adverse Events

Time frame:After 4, 8, 12, 16, 20 and 24 weeks of treatment.

Serious AEs (any)

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Intestinal microbiota

Time frame:Baseline and 24 weeks of treatment

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.