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Clinical Trial NCT07213323 (PROBIO-GLP1) for Obesity &Amp; Overweight, Digestive Disorders is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment (PROBIO-GLP1) 50 Dose Escalation Lifestyle
Clinical Trial NCT07213323 (PROBIO-GLP1) is an interventional study for Obesity &Amp; Overweight, Digestive Disorders and is currently not yet recruiting. Enrollment is planned to begin on December 15, 2025 and continue until the study accrues 50 participants. Led by Hospices Civils de Lyon, this study is expected to complete by December 15, 2027. The latest data from ClinicalTrials.gov was last updated on October 8, 2025.
Brief Summary
Obesity is a prevalent chronic disease affecting 17% of the French population. Treatment involves multiple factors, with pharmacotherapy playing an increasingly important role. GLP-1 receptor agonists (GLP1 RAs) are considered revolutionary in obesity treatment, with three approved molecules available in France: liraglutide, semaglutide, and tirzepatide. These treatments, combined with a healthy lifestyle, induce sig...Show More
Detailed Description
Obesity is a prevalent chronic disease affecting 17% of the French population. Treatment involves multiple factors, with pharmacotherapy playing an increasingly important role. GLP-1 receptor agonists (GLP1 RAs) are considered revolutionary in obesity treatment, with three approved molecules available in France: liraglutide, semaglutide, and tirzepatide. These treatments, combined with a healthy lifestyle, induce sig...Show More
Official Title
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
Conditions
Obesity &Amp; OverweightDigestive DisordersOther Study IDs
- PROBIO-GLP1
- 69HCL25_0321
- 2025-A01248-41 (Other Identifier) (ID-RCB)
NCT ID Number
Start Date (Actual)
2025-12-15
Last Update Posted
2025-10-08
Completion Date (Estimated)
2027-12-15
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
GLP1 R-agonist
Probiotics
Quality of life
Probiotics
Quality of life
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalProbiotics Obese subjects who are going to start a GLP-1 R-agonist (semaglutide or tirzepatide) as part of their weight management in routine clinical practice will received during 26 weeks 1 capsule a day every morning of probiotics that will begin 2 weeks before the initiation of semaglutide or tirzepatide treatment. | Probiotics (Natural product) Participants will be instructed to daily take, during 26 weeks (that will begin 2 weeks before the initiation of semaglutide or tirzepatide treatment) one capsule of a probiotic with water at room temperature with the first meal.
Dosage levels: 1 capsule Digestive Quality of life during the study will be assessed. |
Placebo ComparatorPlacebo Obese subjects who are going to start a GLP-1 R-agonist (semaglutide or tirzepatide) as part of their weight management in routine clinical practice will received during 26 weeks 1 capsule a day every morning of PLACEBO that will begin 2 weeks before the initiation of semaglutide or tirzepatide treatment. | Placebo Participants will be instructed to daily take, during 26 weeks (that will begin 2 weeks before the initiation of semaglutide or tirzepatide treatment) one capsule of PLACEBO with water at room temperature with the first meal.
Digestive Quality of life during the study will be assessed. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Assessment of the Limitation of the impairment in digestive quality of life during the dose escalation of GLP1-RA (semaglutide or tirzepatide) | Assessment using partial GIQLI Score (5 items: 1,27,31,32,33 of the total GIQLI) in each GLP-1 RA group measured 4 weeks following the previous dose escalation, with the GLP1-RA dose standardized on a 0-1 scale.
Item 1 for abdominal pain, Item 27 for dyspepsia, Item 31 for diarrhea, item 32 for constipation and Item 33 for nausea.
For each item, 5 responses will be proposed to the patients and for each answer, a score ranging from 0 to 4 will be assigned The highest score is 20 and defines a more favorable health state | Every 5 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Digestive quality of life | Comparison between the probiotic group and placebo group in the whole population and in the subpopulation of subjects having reached the planned GLP-1 RA treatment dose at 24 weeks, according to the dose escalation design:
Evolution of the partial GIQLI Scores (Questions 1,27,31,32,33). Item 1 for abdominal pain, Item 27 for dyspepsia, Item 31 for diarrhea, item 32 for constipation and Item 33 for nausea.
For each item, 5 responses and for each answer, a score ranging from 0 to 4. The highest score is 20 and defines a more favorable health state | From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment |
Nausea | Comparison of nausea between the probiotic group and placebo group in the whole population and in the subpopulation of subjects having reached the planned GLP-1 RA treatment dose at 24 weeks, according to the dose escalation design:
Evolution of partial GIQLI score (question 33) of nausea score ranging from 0 to 4.
4 defines the more favourable score | From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment |
Dyspepsia | Comparison of dyspepsia between the probiotic group and placebo group in the whole population and in the subpopulation of subjects having reached the planned GLP-1 RA treatment dose at 24 weeks, according to the dose escalation design:
Evolution of partial GIQLI score (question 27) of dyspepsia score ranging from 0 to 4.
4 defines the more favourable score | From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment |
Diarrhea | Comparison of diarrhea between the probiotics group and placebo group in the whole population and in the subpopulation of subjects having reached the planned GLP-1 RA treatment dose at 24 weeks, according to the dose escalation design:
Evolution of partial GIQLI score (question 31) of diarrhea score ranging from 0 to 4.
4 defines the more favourable score | From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment |
Constipation | Comparison of constipation between the probiotic group and placebo group in the whole population and in the subpopulation of subjects having reached the planned GLP-1 RA treatment dose at 24 weeks, according to the dose escalation design:
Evolution of partial GIQLI score (question 32) of constipation score ranging from 0 to 4.
4 defines the more favourable score | From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment |
Abdominal pain | Comparison of abdominal pain between the probiotic group and placebo group in the whole population and in the subpopulation of subjects having reached the planned GLP-1 RA treatment dose at 24 weeks, according to the dose escalation design:
Evolution of partial GIQLI score (question 1) of abdominal pain score ranging from 0 to 4.
4 defines the more favourable score | From baseline to 4, 8, 12, 16, 20 and 24 weeks of treatment |
GLP-1 receptor agonist dosage | Average GLP-1 RA dose | 4, 8, 12, 16, 20 and 24 weeks of intervention |
GLP1-RA dose escalation | Proportion of patients having reached the planned GLP-1 RA treatment dose according to the dose escalation protocol at 4, 8, 12, 16, 20 and 24 weeks | 4, 8, 12, 16, 20 and 24 weeks of intervention |
GLP1-RA dose discontinuation/maintenance | Proportion of patients who had to reduce or to interrupt definitively their GLP-1 RA treatment dose at 4, 8, 12, 16, 20 and 24 weeks | 4, 8, 12, 16, 20 and 24 weeks of intervention |
Weight loss | Percent of weight change from baseline | 4, 8, 12, 16, 20 and 24 weeks of intervention |
Weight loss | absolute change in body weight from baseline | 4, 8, 12, 16, 20 and 24 weeks of intervention |
Weight loss | Rate of patients achieving a body weight reduction of ≥5%, ≥10%, ≥15% | 4, 8, 12, 16, 20 and 24 weeks of intervention |
Quality of life assessed with GIQLI questionnaire | This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to the patients and for each answer, a score ranging from 0 to 4 (highest score = 144) will be assigned. A high score defines a more favorable health state. | baseline, 12 and 24 weeks of treatment |
Quality of life assessed with SF36 questionnaire | This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health | baseline, 12 and 24 weeks of treatment |
Fat mass | Measurement of fat mass will explore the body composition. Results will be expressed in kg and % | Baseline, before implementation of GLP1-RA, 12 and 24 weeks of treatment |
Lean mass | Measurement of lean mass will explore the body composition. Results will be expressed in kg and % | Baseline, before implementation of GLP1-RA, 12 and 24 weeks of treatment |
Skeletal muscle mass | Measurement of skeletal muscle mass will explore the body composition. Results will be expressed in kg and % | Baseline, before implementation of GLP1-RA, 12 and 24 weeks of treatment |
Adverse Events | The safety will be assessed by the Number of adverse events, linked or not to the study product | After 4, 8, 12, 16, 20 and 24 weeks of treatment. |
Severe Adverse Events | The safety will be assessed by the number of severe adverse events, linked or not to the study product | After 4, 8, 12, 16, 20 and 24 weeks of treatment. |
Intestinal microbiota | Fecal microbiota composition | Baseline and 24 weeks of treatment |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
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
Hospices Civils de LyonStudy Central Contact
Contact: Emmanuel DISSE, PUPH, +33478861484, [email protected]
Contact: Dominique DELAUNAY, PhD, +33472110064, [email protected]
1 Study Locations in 1 Countries
Hôpital Lyon Sud, Pierre-Bénite, 69495, France
Emmanuel DISSE, MD PhD, Contact, +33478861484, [email protected]