Antidiarrhoea Clinical Trial
Official title:
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
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.
There is a diabetes pandemic: The number of diabetes patients is expected to reach 500
million worldwide by 2030, of which 90% suffering from type 2 diabetes.
Therapeutically, metformin remains the only recommended first-line treatment. However, the
common digestive effects of this molecule, concerning 30 to 50% of patients, are a major
obstacle to its prescription. The availability of a treatment preventing these unwanted
effects would optimise the treatment of millions of diabetes patients. This would represent a
considerable advantage in terms of public health due to the expected reduction in
cardiovascular morbidity.
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. 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.
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