SAFETY OF LACTOBACILLUS REUTERI IN HEALTHY CHILDREN AGES 2 TO 5 YEARS IN PER

Not Applicable

• Conditions: -A09 Diarrhoea and gastroenteritis of presumed infectious origin; Diarrhoea and gastroenteritis of presumed infectious origin; A09

• Registration Number: PER-065-14
• Lead Sponsor: Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-03
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Children ages 2-5 years with no exclusion criteria

Exclusion Criteria

1) No enrollment of family members in households where any of the following are present:
a. Another study participant in the household
b. Pregnancy or current breastfeeding by any household member
c. Presence of an infant under age 6 months living in the household
d. Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids and methotrexate, etc.) by any household member
e. Presence of a serious congenital anomaly or chronic medical condition that in the opinion of the investigators would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality

2) Allergy to penicillin or cephalosporins or gentamicin
3)History of antibiotic use in the last 30 days
4)Use of probiotic products within the past 90 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.
5)History of diarrheal illness within the past 30 days
6)Presence of fever or a pre-existing adverse event monitored in the study
7)Positive results on serum diagnostic tests for antibodies to HIV
8)Presence of severe anemia, defined as serum hemoglobin <8 gm/dL
9)Out of range laboratory values for tests monitored as potential adverse events.
10)Pre-enrollment stool sample (collected within 14 days of Day 1 of the study) is positive for L. reuteri by PCR.

Study & Design

• Study Type: Interventional
• Study Design: Not specified