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Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants

NCT03477669 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-08-25

No results posted yet for this study

Summary

The objective of this study is to determine the efficacy of a product combining the probiotic Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants. The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty subjects will be randomly assigned to each group for a total enrollment of 60 infants.

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

chamomile/probiotic arm

Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.

DIETARY_SUPPLEMENT

Placebo of chamomile/probiotic arm

Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Ruben E Quiros, MD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-18
Primary Completion
2019-02-25
Completion
2019-02-25

Countries

  • United States

Study Locations

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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 NCT03477669 on ClinicalTrials.gov