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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Functional Diarrhea of Unknown Origin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study is interventional Phase 1 without individual benefit.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Diosmectite (Smecta®)

5 weeks of diosmectite 3g, 3 times daily.

Group Type EXPERIMENTAL

Diosmectite (Smecta®)

Intervention Type DRUG

Interventions

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Diosmectite (Smecta®)

Intervention Type DRUG

Eligibility Criteria

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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).