Colic
Conditions
Keywords
Colic, Colic in Breast-fed Infants
Brief summary
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri
5 drops of study product 30 minutes before feeding.
Sponsors
Children's Investigational Research Program, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Days to 60 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of responders versus non-responders with L. reuteri versus placebo at end of the study. | 21 days |
Countries
United States
Contacts
Primary ContactMisty R Ross, MA
Outcome results
None listed