Trial | NCT01067027  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    Colic

  • Study Participants

    50
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
Study Started
Jun 30
2009
Primary Completion
Dec 31
2011
Anticipated
Study Completion
Jun 30
2012
Anticipated
Last Update
Jun 29
2011
Estimate

Dietary Supplement Lactobacillus reuteri

5 drops of study product 30 minutes before feeding.

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
No Results Posted