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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Investigational Research Program, LLC.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014