Clinical trial NCT03045926: Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Official title: Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Functional Diarrhea of Unknown Origin
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-02-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is interventional Phase 1 without individual benefit.
Primary purpose: OTHER

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 125.
measure: Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
measure: Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period
timeFrame: Screening and pre-dose Day -1 up to Day 95.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
city: Manchester
country: United Kingdom
facility: MAC Clinical Research Limited
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Da Silva K, Guilly S, Thirion F, Le Chatelier E, Pons N, Roume H, Quinquis B, Ehrlich SD, Bekkat N, Mathiex-Fortunet H, Sokol H, Dore J. Long-term diosmectite use does not alter the gut microbiota in adults with chronic diarrhea. BMC Microbiol. 2022 Feb 12;22(1):54. doi: 10.1186/s12866-022-02464-7.