CompletedPhase 1

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

Netherlands, United Kingdom35 participantsStarted 2016-08

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period

Timeframe: Screening and pre-dose Day -1 up to Day 125.

Trial details

NCT IDNCT03045926

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05-09

Results submitted2018-11-14

View on ClinicalTrials.gov More Chronic Functional Diarrhea of Unknown Origin trials