Colic, Infantile
Conditions
Keywords
Colic, Probiotic, Infant
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTL. reuteri
Probiotic
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
For the 2 Randomized arms, all parties were masked. For the 2 Parent Preference arms, all parties were unmasked (open label)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined infant daily cry/fuss duration | Baseline | The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant daily fuss duration | Baseline, 6 and 12 weeks of age | Daily fuss duration will be examined separately |
| Infant colic | 12 weeks | Daily cry/fuss of at least 180 minutes |
| Infant daily sleep duration | Baseline | Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock. |
| Parent (female and male) mental health | Baseline | Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scores range between 0 and 30 and higher scores mean worse outcome. |
| Parent (female and male) fatigue | Baseline | Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome |
| Infant daily cry duration | Baseline | Daily cry duration will be examined separately |
| Adverse effects - digestive upset | 8 weeks | Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary |
| Adverse effects - growth/length | 8 weeks | Infant growth (length) will be measured at scheduled health supervision visits |
| Adverse effects - growth/weight | 8 weeks | Infant growth (weight) will be measured at scheduled health supervision visits |
| Adverse effects - growth/head circumference | 8 weeks | Infant growth (head circumference) will be measured at scheduled health supervision visits |
| Health services utilization | Baseline | Frequency of assessments |
| Gut microbial composition, diversity and function | Baseline | Microbial composition, diversity and function will be measured in infant fecal samples. |
Countries
Canada
Outcome results
None listed