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

Primary Purpose

Colic

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus reuteri
Sponsored by
Children's Investigational Research Program, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colic focused on measuring Colic, Colic in Breast-fed Infants

Eligibility Criteria

14 Days - 60 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Investigational Research ProgramRecruiting

Outcomes

Primary Outcome Measures

* 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.

Secondary Outcome Measures

Number of responders versus non-responders with L. reuteri versus placebo at end of the study.

Full Information

First Posted
February 9, 2010
Last Updated
June 28, 2011
Sponsor
Children's Investigational Research Program, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01067027
Brief Title
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
Official Title
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Investigational Research Program, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
Keywords
Colic, Colic in Breast-fed Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Intervention Description
5 drops of study product 30 minutes before feeding.
Primary Outcome Measure Information:
Title
* 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
Secondary Outcome Measure Information:
Title
Number of responders versus non-responders with L. reuteri versus placebo at end of the study.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Misty R Ross, MA
Phone
479-254-6772
Ext
21
Email
mross@chirpresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan M Harvey, M.D.
Organizational Affiliation
Children's Investigational Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Investigational Research Program
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misty R Ross, MA
Phone
479-254-6772
Ext
21
Email
mross@chirpresearch.com
First Name & Middle Initial & Last Name & Degree
Tonya D Hogue, Coordinator
Phone
479-254-6772
Ext
22
Email
thogue@chirpresearch.com

12. IPD Sharing Statement

Learn more about this trial

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

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