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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) (INDIGO)

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ClinicalTrials.gov Identifier: NCT04065529
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
AXONAL-BIOSTATEM
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Brief Summary:
To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.

Condition or disease Intervention/treatment Phase
Diarrhea Combination Product: Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation Combination Product: placebo + ORS + Zinc supplementation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional, randomized, controlled, double blind, multicenter phase III clinical trial.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacite et Innocuite du Tannate de Gelatine Dans le Traitement de la Diarrhee aiguë de l'Enfant. Une Etude Randomisee, Controlee, en Double Aveugle (INDIGO)
Estimated Study Start Date : August 29, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Gelatin tannate (GT)
Gelatin tannate (GT)
Combination Product: Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation
Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation

Placebo Comparator: Placebo
Placebo
Combination Product: placebo + ORS + Zinc supplementation
placebo + ORS + Zinc supplementation




Primary Outcome Measures :
  1. Duration of diarrhea [ Time Frame: 48 hours ]
    Duration of diarrhea, defined as the time between start of diarrhea and the normalization of stool consistency according to the BSF or BITSS (in BSF scale, =3 or =4; in BITSS, =2), or/and the time until the normalization of the number of stools (compared with the period before the onset of diarrhea), and the presence of normal stools for 48 h.



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Ages Eligible for Study:   3 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065529


Contacts
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Contact: Issatou B DIALLO 0022564352050 issatou.diallo@mct-cro.com
Contact: Principal Investigator aldiouma.diallo@ird.fr

Locations
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Senegal
Niakhar Center IRD Not yet recruiting
Dakar, Senegal, 18524
Contact: Aldiouma Diallo, MS       aldiouma.diallo@ird.fr   
Sub-Investigator: El Hadj Ba         
Sub-Investigator: Assane Diouf         
Sponsors and Collaborators
Ferrer Internacional S.A.
AXONAL-BIOSTATEM
Investigators
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Principal Investigator: Aldiouma Diallo, MS IRD Senegal (Niakhar Center IRD BP 1386 Hann Mariste, CP 18524 Dakar. Sénégal.
Study Director: Javier Xllop Noventure SL

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Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT04065529     History of Changes
Other Study ID Numbers: E870
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferrer Internacional S.A.:
Diarrhea; gastroenterology; acute gastroenteritis; gastroenteritis; acute; gelatin; tannate
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Dextrans
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Plasma Substitutes
Blood Substitutes