Recruiting

Lactobacillus Reuteri

Sponsor:

Children's Investigational Research Program, LLC

Code:

NCT01067027

Conditions

Colic

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Lactobacillus reuteri

Study Details

Brief summary:

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

Conditions

Colic

Study ID

NCT01067027

Start date

Jun, 2009

Status verified date

Jun, 2011

Completion date

Jun, 2012

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Lactobacillus reuteri

5 drops of study product 30 minutes before feeding.

Primary outcome measure

  • * 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 ]

Central Contacts and Locations

Central contacts

Misty R Ross, MA

479-254-6772mross@chirpresearch.com

Locations

Children's Investigational Research Program

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Misty R Ross, MA

479-254-6772mross@chirpresearch.com

Tonya D Hogue, Coordinator

479-254-6772thogue@chirpresearch.com

More Information

Sponsor

Children's Investigational Research Program, LLC

Last update posted

Jun 29, 2011

Last verified

Jun, 2011

Keywords

  • Colic
  • Colic in Breast-fed Infants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Investigational Research Program, LLC on 2011-06-29.