Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT06192693
Eligibility Criteria:
Inclusion Criteria patients :
* Adult patients from 18-65 years old
* T2D patients any severity of initial T2D disease before BS
* Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
* Non-Diabetic remission (NDR) patients 1-year post-BS, defined as Hba1c\>6.5% and/or fasting glycaemia\>6.9mmol/l and/or receiving anti-diabetic drugs for at least 2 months. We will rather select patients with uncontrolled diabetes with Hba1c\>7% and willing to receive proton pump inhibitor (PPI)
* Patient compliant to 1rd year follow-up post-BS (who came to at least 2 among the three routine care follow-up visits during the first year (i.e. 3, 6 and 12M)
* Signature of the informed consent
* Affiliated to a social security regime (except AME)
Exclusion Criteria patients :
* Type 1 diabetes
* Patients receiving antibiotics (ATB) at the selection time or within the 3 previous months (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
* Immunosuppressive therapy
* Laxative treatments
* DR since BS (nor relapse patients detailed further in the protocol)
* Patients already recruited in another interventional studies study where a drug is being tested
* Pregnant or breastfeeding women
* Patient with contemporary disease such as intestine disease
* Patient under guardianship or curatorship
* Patient deprived of their liberty by a judicial or administrative decision
Inclusion criteria donors:
* Age ≥ 18 years and \< 50 years
* Lean individuals (18\<BMI\<25kg/m²)
* Euglycemic: fasting glycemia \<6mmol/l; Hba1c \<5.9%
* Healthy: no current drug prescription (except contraception or pain killers other than AINS)
* Regular bowel movement in the morning defined as 1 stool/day at least
* Signature of the informed consent
* Subject with health insurance (except AME)
Exclusion criteria donors:
* Familial history of obesity or diabetes and personal history of overweight/obesity
* Infectious risk
* Gastrointestinal disease
* Exclusion criteria according screening test to National Agency for the Safety of Medicines and Health Products (ANSM) recommendations
* Pregnancy or breastfeeding women
* Subject under guardianship or curatorship
* Subject deprived of their liberty by a judicial or administrative decision
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06192693
Study Brief:
Protocol Section:
NCT06192693