NCT02169817

Brief Summary

Primary Objective: To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children. Secondary Objectives: To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes. To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
629

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2014

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

June 18, 2014

Last Update Submit

January 20, 2016

Conditions

Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary

    from Day 1 to Day 5

Secondary Outcomes (6)

  • Mean number of stools per day

    Day 1 to Day 5

  • Effect on consistency of stool

    Day 1 to Day 5

  • Number of vomiting episodes per day

    Day 1 to Day 5

  • Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina

    Day 1 to Day 5

  • Parent / Legal guardian's assessment of children's overall general state

    Day 1 to Day 5

  • +1 more secondary outcomes

Study Arms (1)

Enterogermina + Enterolyte

EXPERIMENTAL

2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation

Drug: Bacillus clausiiDrug: Oral Rehydration Therapy

Interventions

Bacillus clausiiDRUG

Pharmaceutical form:aqueous suspension Route of administration: oral

Also known as: Enterogermina
Enterogermina + Enterolyte
Oral Rehydration TherapyDRUG

Pharmaceutical form:vials/sachets for solution Route of administration: oral

Also known as: Enterolyte
Enterogermina + Enterolyte

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period):
  • with less than 48 hours duration
  • aged between 6 months and 5 years of age
  • whose parents or legal guardians have given their written informed consent
  • with clinical indication for ORT per formula of World Health Organization

You may not qualify if:

  • Infants or children with:
  • presence of blood, pus, or mucus in stools
  • severe dehydration
  • untreatable vomiting
  • antibiotics indication for the treatment of this acute diarrhea;
  • hospitalization
  • expected hospitalization for the next hours due to the poor clinical conditions
  • treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted)
  • previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
  • indication of any other ORT different from the one prescribed in the study
  • chronic diseases including chronic diarrhea
  • immunodeficiency (acquired or congenital immunodeficiency)
  • other infectious comorbid conditions
  • known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics
  • parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

04

Pilar, Buenos Aires, Argentina

Location

01

Mar del Plata, Argentina

Location

06

San Miguel de Tucumán, Argentina

Location

076002

Curitiba, Brazil

Location

076006

Porto Alegre, Brazil

Location

076003

Salvador, Brazil

Location

076001

São Paulo, Brazil

Location

170002

Armenia, Colombia

Location

484010

Mexico City, Mexico

Location

604001

Lima, Peru

Location

604003

Lima, Peru

Location

MeSH Terms

Interventions

clausin peptide, Bacillus clausiiFluid Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 23, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

PE(2)ME(1)AR(3)BR(4)CO(1)