Study of the Efficacy and Tolerance of Oral Treatment With a Total Freeze-dried Culture of Lcr Restituo® Sachets (Lactobacillus Rhamnosus Lcr35®) on Intolerance to Metformin (Diarrhoea) in Patients With Diabetes Type 2 (PROVAME)

This is an interventional prevention trial for Antidiarrhoea focused on measuring diarrhoea, metfomin, type 2 diabetes, microbiota Read More

Inclusion Criteria:

Disease-related

• Patients who, from a metabolic perspective, could benefit from metformin treatment, namely patients for whom the latest available hemoglobin glycated (HbA1c) is no older than 3 months, and higher that suggested in recommendations, and lower than 9%.
• Patients with type 2 diabetes who have not received metformin treatment for at least 2 months, or treated with a non-optimal dose of metformin, i.e. 1500 mg/day or less, due to a history of diarrhoea-type digestive intolerance reported with this drug.
• Patients who at the time of entering the study have a blood sugar self-monitoring device.
• Patients whose kidney function, evaluated in reference to creatinine clearance calculated using the Cockcroft formula, is 45ml/min or higher.

Cohort-related:

• Patients aged between 18 and 75 years

• For women of childbearing age:

  • to have a negative urine pregnancy test,
  • and use a contraceptive method deemed effective by the investigator throughout the trial
• Patient able to speak and read French, having been informed of the study, and having voluntarily signed an Informed Consent Form
• Patient covered by a social security scheme

Exclusion Criteria:

Disease-related:

• Patient presenting with cardinal signs of diabetes
• Patients presenting with chronic diarrhoea or with a history of chronic intestinal inflammatory disease or having presented with an episode of acute diarrhoea in the 10 days preceding the inclusion.

Treatment-related:

• Patients presenting with a contraindication to metformin treatment other than diarrhoea-type digestive intolerance manifestations.
• Patients treated with a Inhibitors of dipeptidyl peptidase 4 (DPP-IV inhibitor).
• Patients who presented with a serious adverse event associated with metformin prescription.
• Patients who have taken orlistat in the preceding month or who have taken antibiotics in the preceding month.
• Patients who have taken probiotics in the month preceding the inclusion visit.
• Patients who have taken prebiotics in the 15 days preceding the inclusion visit.
• Patients who have an allergy to one of the active ingredients or one of the excipients in the study product.

Cohort-related:

• Patient with no referring physician.
• Patient deemed by the investigator as unable to participate in the study
• Patient unable to comply with the constraints of the protocol.
• Patient whose metabolic condition does not justify the initiation or dose increase of metformin treatment.
• History of bariatric surgery.
• Patient is immunodeficient, or has a chronic viral infection with the hepatitis B or C, or the human immunodeficiency virus (HIV virus)
• Patient is pregnant, planning a pregnancy, or without contraception.
• Breastfeeding patient.
• Patient with a previous illness which, according to the investigator, is likely to interfere with the study results or expose the patient to an additional risk.
• Patient linguistically unable (unable to speak or write French) or mentally unable to understand and sign the Informed Consent Form.
• Patient deprived of their liberty by order of the Courts or civil authorities or subject to a guardianship order.
• Patient who is likely to not comply with treatment.
• Patient unable to be contacted in the case of an emergency.