Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants (CRI)
Status
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Treatments
Details and patient eligibility
About
Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy, term infant from a singleton birth (=>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour
Exclusion criteria
- Infants with known genetic syndromes; birth weight (<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
Trial design
Primary purpose
Allocation
Interventional model
Masking
1 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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