Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

• Status: Completed
• Trial end date: 2017-05-09
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to assess the concentration of elemental impurities in blood and urine after chronic administration of Smecta® in subjects with chronic functional diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote composition will be investigated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

Criteria

Inclusion Criteria:

• Male or female subjects, between 18 and 60 years old inclusive, BMI between 19 and 32 kg/m2 inclusive (minimum body weight of 50 kg at screening).

• Functional chronic diarrhoea defined as loose or watery stools occurring in at least 75% of stools for the last 3 months (with symptom onset at least 6 months before diagnosis).

Exclusion Criteria:

• No history of suspected organic or drug induced cause to chronic diarrhoea.