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

This study is currently recruiting participants.
Verified June 2011 by Children's Investigational Research Program, LLC
Sponsor:
Information provided by:
Children's Investigational Research Program, LLC
ClinicalTrials.gov Identifier:
NCT01067027
First received: February 9, 2010
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Colic
 Dietary Supplement: Lactobacillus reuteri
 Phase 4

Study Type: Interventional
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
Official Title: Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by Children's Investigational Research Program, LLC:

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. [ Time Frame: 7, 14 and 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of responders versus non-responders with L. reuteri versus placebo at end of the study. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Lactobacillus reuteri
    5 drops of study product 30 minutes before feeding.
  Eligibility

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067027

Contacts
Contact: Misty R Ross, MA 479-254-6772 ext 21 mross@chirpresearch.com

Locations
United States, Arkansas
Children's Investigational Research Program Recruiting
Bentonville, Arkansas, United States, 72712
Contact: Misty R Ross, MA     479-254-6772 ext 21     mross@chirpresearch.com    
Contact: Tonya D Hogue, Coordinator     479-254-6772 ext 22     thogue@chirpresearch.com    
Sponsors and Collaborators
Children's Investigational Research Program, LLC
Investigators
Principal Investigator: Bryan M Harvey, M.D. Children's Investigational Research Program
  More Information

No publications provided

Responsible Party: Bryan M. Harvey, M.D., Children's Investigational Research Program
ClinicalTrials.gov Identifier: NCT01067027     History of Changes
Other Study ID Numbers: Colic001
Study First Received: February 9, 2010
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Investigational Research Program, LLC:
Colic
Colic in Breast-fed Infants

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 23, 2013