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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-065-14

Enrollment

Registered

2015-03-03

Start date

2014-10-01

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

Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either: A.Lactobacillus reuteri (Lr):

follow-up for 6 months total. Duration of Project Period: 18 months

Eligibility

Sex/Gender

All

Age

2 Years to 5 Years

Inclusion criteria

Inclusion criteria: Children ages 2-5 years with no exclusion criteria

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.

Countries

Peru

Contacts

Public ContactMaribel Paredes

ASOCIACION BENEFICA PRISMA

mparedeso@prisma.org.pe65-234250

Outcome results