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Table 2 The ongoing trials of probiotics and infant colic

From: Probiotics for infantile colic: a systematic review

No Study Inclusion and exclusion criteria Primary outcome Estimated enrollment Arms
1 Effect of L. rhamnosus GG (LGG) on Infant Colic Inclusion Criteria: Crying times of infants 60 Experimental: Nutramigen Lipil with Enflora
Sixty healthy full-term colicky infants (gestational age 32–41 weeks)
Control: Nutramigen A + Hypoallergenic formula without lactobacilli
Exclusion Criteria:
Chronic lung disease,
Diarrhea (stools that take the shape of a container > 5x daily)
Fever
2 Control of Colic in Infants by Dietary Supplementation with the Probiotic L. reuteri Inclusion Criteria: Reduction of daily average crying time to less than 3 hours from baseline 50 Experimental: L. reuteri
Infants aged between 14–60 days
Control: Not clear
Breast fed, exclusively during length of trial
Diagnosis of infantile colic according to Wessel’s criteria
Debut of colic symptoms 6 ± 1 days before randomization
Gestational age between 37–42 weeks
Apgar score higher than 7 at 5 minutes
Mothers willing to follow a cow milk-free diet during the study period
Written informed consent and stated availability throughout the study period
Exclusion Criteria:
Major chronic disease
Gastrointestinal disease but controlled gastroesophageal reflux disease
Administration of antibiotics the week before randomization
Administration of probiotics the week before randomization
Participation in other clinical trials
3 Baby Biotics randomised controlled trial Inclusion criteria Infant crying/fussing time 160 Experimental: L. reuteri DSM 17938.
Infant colic as defined by the modified Wessel’s criteria
(min/day)
Less than 3 months Control: maltodextrose
Greater than 36 weeks gestation at birth
Birth weight of more than 2500 g.
Exclusion criteria
Failure to thrive
Major medical problems
Taking solids, antibiotics or L. reuteri and, if breastfeeding, mother taking
L. reuteri at the time of study commencement;
Cow’s milk protein allergy
Caregiver has insufficient English to understand informed consent and complete questionnaires.