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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.

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 27, 2019
Estimated Study Start Date  ICMJE August 29, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04065529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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 place in public health facilities in Senegal.

Proposed site is the Niakhar Center IRD BP 1386 Hann Mariste, Dakar-Senegal) with the health center of Niakhar as satellite site. More sites can be opened at the discretion of the Sponsor if required

Study design and type:

Interventional, randomized, controlled, double blind, multicenter phase III clinical trial.

Test product/arms:

Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation versus (vs.) placebo + ORS + Zinc supplementation.

Investigational Product: GELATIN TANNATE (GT):

  • Children below 3 years of age: One sachet every 6 hours
  • Children from 3 to 14 years of age: 2 sachets every 6 hours. All patients will take ORS solution according to 2014 European recommendations, and Zinc supplementation.

Reference Product:

Placebo. The dose regimen and mode of administration will be similar as the investigational product.

Number of patients planned:

150 patients, randomized in 1:1 basis (75 in each arm).

Inclusion criteria:

Children eligible for the trial must fulfil ALL of the following 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.

Non-inclusion criteria: In order to participate in this study, all subjects must meet NONE of the following 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 (eg, 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)
  • Subject who previously entered in a clinical study within the past 30 days.
  • Pregnancy and suspected Pregnancy

Study duration: 7 days including 5 days of treatment; follow up at Day 7.

Study outcomes:

Primary outcome:

The primary outcome will be the 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.

A subgroup analysis will be performed with patients for whom the cause of the diarrhea is not parasitic.

Secondary outcomes:

  • Stool Decrease Index (SDI)
  • Time resolution of diarrhea from start of treatment
  • Need for intravenous rehydration
  • Number of watery stools per day
  • Vomiting
  • Weight gain
  • Recurrence of diarrhea (48 h after intervention)
  • Severity of diarrhea according to Vesikari scale
  • Use of concomitant medications.
  • Adverse events (AEs)

Expected results:

Significant decrease of duration of diarrhea with the Gelatin Tannate plus ORS plus zinc than placebo+ ORS +zinc

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Diarrhea
Intervention  ICMJE
  • Combination Product: Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation
    Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation
  • Combination Product: placebo + ORS + Zinc supplementation
    placebo + ORS + Zinc supplementation
Study Arms  ICMJE
  • Experimental: Gelatin tannate (GT)
    Gelatin tannate (GT)
    Intervention: Combination Product: Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Combination Product: placebo + ORS + Zinc supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Issatou B DIALLO 0022564352050 issatou.diallo@mct-cro.com
Contact: Principal Investigator aldiouma.diallo@ird.fr
Listed Location Countries  ICMJE Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065529
Other Study ID Numbers  ICMJE E870
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferrer Internacional S.A.
Study Sponsor  ICMJE Ferrer Internacional S.A.
Collaborators  ICMJE AXONAL-BIOSTATEM
Investigators  ICMJE
Principal Investigator: Aldiouma Diallo, MS IRD Senegal (Niakhar Center IRD BP 1386 Hann Mariste, CP 18524 Dakar. Sénégal.
Study Director: Javier Xllop Noventure SL
PRS Account Ferrer Internacional S.A.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP