BACILLUS CLAUSII IN THE TREATMENT OF ACUTE COMMUNITY–ACQUIRED DIARRHEA AMONG LATIN AMERICAN CHILDREN (CADILAC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-039-14

Enrollment

Registered

2014-11-28

Start date

2014-12-26

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ENTEROGERMINA®: each 5 mL vial contains aqueous suspension of 2 billion spores of Bacillus clausii.

Eligibility

Sex/Gender

All

Age

1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Infants or children • Aged between 6 months and 5 years of age; • With acute community-acquired diarrhea (>3 liquid or watery stools occurring in a 24-hr period) with less than 48 hrs duration; • Whose parents or legal guardians have given their written informed consent; • With clinical indication of ORT per formula described in Table 1.

Exclusion criteria

Exclusion criteria: Infants or children with • Presence of blood, pus, or mucus in stools; • Severe dehydration (WHO criteria); • 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 48hr) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anti-colinergic agents; • Indication of any other ORT different from described below, i.e. not reduced osmolarity, with zync (please see item 8.1); • Chronic diseases including chronic diarrhea; • Immunodeficiency (acquired or congenital immunodeficiency); • Other infectious co-morbid conditions; • Known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics; • Parent/legal guardian who, in the opinion of the Investigator, is unable to fill up the patient diary or bring the child for the follow-up visit; • Participation in another clinical trial in the last 3 months prior to the start of the study.

Countries

Argentina, Brazil, Colombia, El Salvador, Guatemala, Honduras, Mexico, Peru, Venezuela

Contacts

Public ContactFiorella Yabar

SANOFI AVENTIS DEL PERU S.A.

fiorella.yabar-ext@sanofi.com4114710 anexo 5005

Outcome results