2024-511870-65-00招募中3 期
Diabete RemIssion using Fecal TransfER post bariatric surgery (DRIFTER)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Hba1c change from baseline to 6 months post randomization (we expect at least -0.75%)
研究概览
简要总结
To assess Fecal microbiota transfer (FMT) efficacy on Hba1c change from baseline to 6 months (6M=24W) follow-up, in non-diabetic Remission (NDR) patients who underwent Bariatric surgery (BS) 1 to 5 years ago.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •For patients : Adult patients from 18-65 years old
- •For donors : Euglycemic: fasting glycemia <6mmol/l; Hba1c <5.9%
- •For donors : Healthy no current drug prescription (except contraception or pain killers other than AINS)
- •For donors : Regular bowel movement in the morning defined as 1 stool/day at least
- •For donors : Signature of the informed consent
- •For donors : Subject with health insurance (except AME)
- •For patients : T2D patients any severity of initial T2D disease before BS
- •For patients : Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
- •For patients : 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)
- •For patients : 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)
- •For patients : Signature of the informed consent
- •For patients : Affiliated to a social security regime (except AME)
- •For donors : Age ≥ 18 years and < 50 years
- •For donors : Lean individuals (18
排除标准
- •For patients : Type 1 diabetes
- •For patients : Patient under guardianship or curatorship
- •For donors : Familial history of obesity or diabetes and personal history of overweight/obesity
- •For donors : Infectious risk (for more information see the protocol)
- •For donors : Gastrointestinal disease (for more information see the protocol)
- •For donors : Personal or 1st degree family history of autoimmune or inflammatory disease (inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, Hashimoto…)
- •For donors : Factors that may affect the composition of the intestinal microbiota (Special Diet - exclusion diet, vegetarian diet) /Taking immunosuppressants - eg calcineurin inhibitors, corticosteroids, biological agents, etc. / Chemotherapy / Subject with a chronic illness / Curative long-term treatment
- •For donors : Exclusion criteria according screening test : 1/Positive result for one of the contagious diseases testing blood and stool, excepting for IGG positive EBV, CMV and toxoplasma serology according to ANSM recommendations and only positive Ac HBS HBV witness of post-vaccination immunity and HAV Healed / 2 - Carrier of multiresistant bacteria / 3- - Abnormal biological test at inclusion suggesting a pathology: fasting blood glucose, Hba1c, blood count, chemistry panel with determination of urea and creatinine, liver function tests (AST, ALT, GGT, PAL, bilirubin), CRP, hemostasis
- •For donors : Pregnancy or breastfeeding women
- •For donors : Subject under guardianship or curatorship
- •For donors : Subject deprived of their liberty by a judicial or administrative decision
- •For patients : Patient deprived of their liberty by a judicial or administrative decision
- •For donors : Temporary donor’s exclusion criteria - Infectious risk (for mors information see protocol)
- •For patients : 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)
- •For patients : Immunosuppressive therapy
- •For patients : Laxative treatments
- •For patients : DR since BS (nor relapse patients detailed further in the protocol)
- •For patients : Patients already recruited in another interventional studies study where a drug is being tested
- •For patients : Pregnant or breastfeeding women
- •For patients : Patient with contemporary disease such as intestine disease
结局指标
主要结局
Hba1c change from baseline to 6 months post randomization (we expect at least -0.75%)
Hba1c change from baseline to 6 months post randomization (we expect at least -0.75%)
次要结局
- Evolution of Hba1c from baseline to 2 years post randomization Hba1c will be measured at the following visits: baseline 6, 12, 18, 24W, 1 and 2 years post randomization
- Evolution of C-peptide from baseline to 2 years post randomization C-peptide will be measured at the following visits: baseline 6, 12, 18, 24W, 1 and 2 years post randomization
- Evolution of insulin secretion from baseline to 24W using the HOMA-B calculator (=20 × fasting insulin (μIU/ml)/ fasting glucose (mmol/ml) − 3.5)
- Evolution of insulin resistance from baseline to 24W: we will use the HOMA-IR (= fasting insulin (μIU/ml) × fasting glucose (mmol/ml)/ 22.5) and Disse index (=Disse 12*((2.5*(HDL-total cholesterol)-NEFA)-insulin)) which are two complementary markers to evaluate insulin resistance using different parameters.
- Glycaemia profile (using glycemic holter) changes from baseline to 6W and 24W
- Number of antiT2D drugs. The number of concomitant anti-diabetic drugs will be analysed at baseline and at 1 and 2 years’ post-randomization.
- Type of antiT2D drugs. The type of anti-diabetic drugs will be analysed at baseline and 1 and 2 years’ post-randomization, modifications will be described.
- Number of patients reaching DR. Proportion of patients reaching DR (partial or complete) at 24W and maintaining it at 1 and 2 years. Partial diabetes remission (PDR) is defined as Hba1c <6.5% and FPG <7.0 mmol/l without the need of glucose- lowering agents. Complete diabetes remission (CDR) is defined as Hba1c <6.0% and FPG <5.6 mmol/l without glucose-lowering agents
- Proportion of patient needing a “safety” glucose lowering treatment to control Hba1c despite FMTs
- Describe how long the FMT effects last (i.e. time with 1st HbA1c at least 0.15% lower than baseline value)
- Describe how many FMT cures are needed to obtain the primary end-point (-0.75% reduction of Hba1c)
- Evaluate the proportion of good responders’ patients (Good responders are defined in the protocol)
- Identify characteristics of good response related to the receiver (more detail in protocol)
- Identify characteristics of good response related to good donor’s (i.e. factors from the donor associated with good response in the receiver)
- Identify gut microbiota signature (i.e. dominant/subdominant bacteria/taxa/ genus/ species) associated with good response of FMT, in the receiver post-FMT (at 6 and 12W) (metagenomic analysis as described above)
- Changes in gut microbiota MGR and microbiota composition in receivers from baseline to 6, 18 and 24W follow-up (with further comparison between good/bad responders)
- Changes in systemic gut microbiota related metabolites (LC-MS metabolomics) from baseline to 6, 18 and 24W)
- Evaluate FMT safety (more detail in protocol)
- Evaluate changes in quality of life after capsulized FMT (baseline vs. after FMT and between treatment groups using SF36 questionnaire)
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (2)
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