Status:
COMPLETED
Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in the Treatment of Acute Diarrhea (INDIGO)
Lead Sponsor:
Ferrer Internacional S.A.
Collaborating Sponsors:
Axonal-Biostatem
Conditions:
Diarrhea
Eligibility:
All Genders
3-14 years
Phase:
PHASE3
Brief Summary
To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.
Detailed Description
Study purpose: To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution. Study centers/ settings: The recruitment will take pla...
Eligibility Criteria
Inclusion
- AGE defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale ≥ 6 or, the Brussels Infant and Toddler Stool Scale (BITSS) =4 in the case of infants ≤ 3 years (see Annex 1) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h),
- AGE lasting between 1 day and 2 days;
- Children from 3 months old
- Children up to 14 years old;
- Written informed consent form signed by parents or legal guardians must be provided to caregivers.
- Subject willing and able to comply with study restrictions and willing to return to the health center and to perform the follow-up evaluation as specified in the protocol.
Exclusion
- Use of antibiotics, diosmectite, probiotics, racecadotril, loperamide or zinc (including zinc containing ORS) within a week prior to enrolment
- Chronic diarrheal gastrointestinal disease (e.g, inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy)
- Immunodeficiencies
- Signs of malnutrition according to the opinion of the investigator (weight/height under 3rd z score as per World Health Organization \[WHO\] Child Growth Standards)
- Need for Intravenous rehydration
- Subject who previously entered in a clinical study within the past 30 days.
- Pregnancy and suspected Pregnancy
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04065529
Start Date
September 11 2019
End Date
June 11 2020
Last Update
November 4 2020
Active Locations (1)
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1
Niakhar Center IRD
Dakar, Senegal, 18524