Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

June 28, 2011 updated by: Children's Investigational Research Program, LLC
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Recruiting
        • Children's Investigational Research Program
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ifants aged between 14 and 60 days
  • Breast fed, exclusively during length of trial
  • Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
  • Debut of colic symptoms 6+/-1 days before randomization
  • Gestational age between 37 and 42 weeks
  • Apgar score higher than 7 at 5 minutes
  • Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
  • Written informed consent from one or both parents
  • Stated availability throughout the study period

Exclusion Criteria:

  • Major chronic disease
  • Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
  • Administration of anitbiotics the week before randomization
  • Administration of probiotics the week before randomization
  • Participation in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.
Time Frame: 7, 14 and 21 days
7, 14 and 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of responders versus non-responders with L. reuteri versus placebo at end of the study.
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Investigational Research Program, LLC

Investigators

  • Principal Investigator: Bryan M Harvey, M.D., Children's Investigational Research Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 28, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Colic001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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