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Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

NCT01849991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-01-30

No results posted yet for this study

Summary

This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.

Conditions

  • Gastrointestinal
  • Colic

Interventions

BIOLOGICAL

Lactobacillus reuteri

Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily.

BIOLOGICAL

Placebo

Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • J. Marc Rhoads, M.D. · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01849991 on ClinicalTrials.gov