A Double-blind, Mylti-center, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colic, Infantile
- Sponsor
- BioGaia AB
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Crying and fussing time
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
Detailed Description
Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers. Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged between 3-8 weeks at screening.
- •Gestational age 37+0 weeks - 42+0 weeks at birth.
- •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.
- •Parents/caregivers/legal guardians are \>18 years.
- •Exclusively or predominantly breastfed infants (\> 50 % breast fed).
- •Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
- •Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
- •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.
- •Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- •Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Crying and fussing time
Time Frame: From baseline to Day 7
Change in daily crying and fussing time measured by Baby Day Diary
Secondary Outcomes
- Number of responders(From baseline to Day 3, Day 5, Day 7, Day 14, Day 21)
- Sleeping time(From baseline to Day 3, Day 5, Day 7, Day 14, Day 21)
- Family quality of life (family QoL)(From baseline to Day 7 and Day 21)
- Maternal depression(From baseline to Day 7 and Day 21)
- Crying time(From baseline to Day 3, Day 5, Day 7, Day 14, Day 21)
- Crying and fussing time(From baseline to Day 3, Day 5, Day 14, Day 21)