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

Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01067027
• Other study ID #: Colic001
• Status: Recruiting
• Phase: Phase 4
• First received: February 9, 2010
• Last updated: June 28, 2011
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2011
• Source: Children's Investigational Research Program, LLC
• Contact: Misty R Ross, MA
• Phone: 479-254-6772
• Email: mross[@]chirpresearch.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 60 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic

Intervention

Dietary Supplement:
• Lactobacillus reuteri
5 drops of study product 30 minutes before feeding.

Locations

Country	Name	City	State
United States	Children's Investigational Research Program	Bentonville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Children's Investigational Research Program, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	* 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.		7, 14 and 21 days	No
Secondary	Number of responders versus non-responders with L. reuteri versus placebo at end of the study.		21 days	No