Infantile Colic
Conditions
Brief summary
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
Interventions
DIETARY_SUPPLEMENTL. reuteri
Supplementation with drops containing L. reuteri once daily for 21 consecutive days
DIETARY_SUPPLEMENTPlacebo
Supplementation with identical drops without L. reuteri once daily for 21 consecutive days
Sponsors
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 12 Weeks
Healthy volunteers
No
Inclusion criteria
1. Aged between 3-12 weeks at screening. 2. Gestational age 37+0 weeks - 42+0 weeks at birth. 3. Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides. 4. Parents/caregivers/legal guardians are \>18 years. 5. Exclusively or predominantly breastfed infants (\> 50 % breast fed). 6. Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.). 7. Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires. 8. Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time. 9. Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator. 10. Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study. 11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22). 12. Infant is considered healthy, in the opinion of the investigator following physical exam.
Exclusion criteria
1. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis). 2. Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians. 3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease. 4. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period. 5. Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period. 6. Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crying and fussing time | From baseline to Day 7 | Change in mean crying and fussing time as assessed by the Baby's Day Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crying and fussing time | From baseline up to Day 21 | Change in mean crying and fussing time as assessed by the Baby's Day Diary |
| Number of responders | From baseline up to Day 21 | Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline |
| Family Quality of Life | From baseline up to Day 21 | Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score |
| Sleeping time | From baseline up to Day 21 | Change in mean sleeping time as assessed by Baby´s Day Diary |
| Maternal depression | From baseline up to Day 21 | Change in maternal depression as assessed by the Edinburgh Postnatal Depression Scale Total Score |
Countries
Bulgaria
Contacts
Primary ContactSanna Nyström, PhD
Backup ContactPetra J Lierud
Outcome results
None listed