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. |