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)

NCT04065529 | Completed Phase 3

• 1 other identifier: E870
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhea

Keywords

Diarrhea; gastroenterology; acute gastroenteritis; gastroenteritis; acute; gelatin; tannate

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhea

  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.

  48 hours

Study Arms (2)

Gelatin tannate (GT)

EXPERIMENTAL

Gelatin tannate (GT)

Combination Product: Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation

Placebo

PLACEBO COMPARATOR

Placebo

Combination Product: placebo + ORS + Zinc supplementation

Interventions

Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation COMBINATION_PRODUCT

Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation

Gelatin tannate (GT)

placebo + ORS + Zinc supplementation COMBINATION_PRODUCT

placebo + ORS + Zinc supplementation

Placebo

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead
• Axonal-Biostatem: collaborator

Study Sites (1)

Niakhar Center IRD

Dakar, 18524, Senegal

Location

MeSH Terms

Conditions

Diarrhea; Gastroenteritis

Interventions

tannate gelatin; World Health Organization oral rehydration solution; ORALIT

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Aldiouma Diallo, MS

  IRD Senegal (Niakhar Center IRD BP 1386 Hann Mariste, CP 18524 Dakar. Sénégal.

  PRINCIPAL INVESTIGATOR

• Javier Xllop

  Noventure SL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: August 22, 2019
• Study Start: September 11, 2019
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

SE (1)