PRobiotics for EVEry Newborn Trial (PREVENT)

The Hospital for Sick Children

Status: Unknown

Conditions: Infantile; Colic

Treatments: Dietary Supplement: L. reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT04537494

1000064700

Details and patient eligibility

About

The aim of the study is to compare prevention (oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks) with treatment-as-needed (supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age). This is a single site pilot study to assess feasibility for a full trial.

Full description

One in five infants experience colic, defined as recurrent and prolonged episodes of crying and fussing with no obvious cause in healthy infants less than 5 months of age. There is evidence to support the role of the probiotic L. reuteri for treatment of colic in breastfed babies and for prevention of colic. However, these two options (prevention vs treatment-as-needed) have not been previously compared head-to-head. The study aims determine if oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks (prevention) is superior to treatment-as-needed, as measured by daily cry/fuss duration at 6 and 12 weeks of age.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 1 to 7 days of age
2. term (37 to 41 weeks)
3. breast or formula fed
4. birth weight > 2500 grams
5. parental consent

Exclusion criteria

1. congenital or other medical disorders
2. parents unable to communicate in English or French

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Prevention

Active Comparator group

Description:

Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks

Treatment:

Dietary Supplement: L. reuteri

Treatment-as-needed

Other group

Description:

Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age

Treatment:

Dietary Supplement: L. reuteri