| Trial ID: | L4498 |
| Source ID: | NCT02730741
|
| Associated Drug: |
Lcr Restituo® Sachet
|
| Title: |
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
|
| Acronym: |
PROVAME
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Antidiarrhoea
|
| Interventions: |
DRUG: Lcr restituo® sachet|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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 |
|
| Sponsor/Collaborators: |
Sponsor: Biose
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2016-06
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2018-01-19
|
| Locations: |
BIOSE, Aurillac, France
|
| URL: |
https://clinicaltrials.gov/show/NCT02730741
|
