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

Ipsen

Status and phase: Completed; Phase 1

Conditions: Chronic Functional Diarrhea of Unknown Origin

Treatments: Drug: Diosmectite (Smecta®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03045926

D-FR-00250-108

2016-002111-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Diosmectite (Smecta®)

Experimental group

Description:

5 weeks of diosmectite 3g, 3 times daily.

Treatment:

Drug: Diosmectite (Smecta®)