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

NCT02730741 Phase 2 UNKNOWN

The mechanisms of diarrhoea under metformin are poorly known. Recent data indicate that a change in gut flora might be responsible for this intestinal disorder. The effect of metformin on the gut flora has been extensively described. It has been shown that the therapeutic effect of metformin depends on the microbiota. In agreement with these data, a recent publication has shown that metformin's main site of action in humans was the intestine. In light of these results, it now seems plausible that metformin's effect on the gut flora is responsible not only for its therapeutic effect but also for its undesirable digestive effects. In this respect, Lactobacillus rhamnosus has shown anti-diarrhoeal effects (approximately 50% reduction in diarrhoeas) in the contexts of infection-caused dysbiosis and post-antibiotic dysbiosis. Hypothesis: Taking into account the favourable effect on intestinal dysbiosis-induced diarrhoeas observed with Lactobacillus rhamnosus, we put forward the hypothesis that Lactobacillus rhamnosus Lcr35® will have a favourable effect on metformin-induced diarrhoea.

Details

Lead sponsor	Biose
Phase	Phase 2
Status	UNKNOWN
Enrolment	60
Start date	2016-06

Conditions

• Antidiarrhoea

Interventions

• Lcr restituo® sachet
• Placebo

Primary outcomes

• Compare number of treated patients who have had diarrhoea in the verum group and in the placebo group between Visit 2 and Visit 5. Diarrhoea evaluated using the Bristol stool scale (types 5 to 7) — 3 months

Countries

France