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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.