This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.
Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
Infant is healthy at the time of pre-examination.
Infant is aged between 1 and 14 days old at the time of inclusion.
Legal guardian(s) are able and willing to follow the study instructions
No legal guardian's command of any local language
Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
Infant is suffering from congenital or acquired immunodeficiency
Infant is suffering from an infection at the time of pre-examination or previous 7 days
Parallel
Two probiotic Limosilactobacillus reuteri strains
Dietary supplementEach participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
Placebo
Dietary supplementEach participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.
Peak measured crying time
Peak measured crying time at 6 (±1) weeks according to the prospectively kept baby day diary
The occurrence of infant colic at any time in the first 3 months of life.
The criteria for infant colic are: * Recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers. Fussing refers to intermittent distressed vocalization and refers to behavior that is not quite crying but not awake and content either. * Caregiver reports infant has cried or fussed for 3 or more hours/day during 3 or more days in a given week. * Total 24-hour crying plus fussing in the selected group of infants is confirmed to be 3 hours or more when measured by at least one, prospectively kept, 24-hour behavior diary.
Peak measured fussiness time
Peak measured fussiness time at the age of 6 (±1) weeks according to the prospectively kept baby day diary.
Overall crying and/or fussiness time
Overall (estimated + measured) crying and/or fussiness time in the first 3 months (±1 week) of life.
Overall unconsolable crying time
Overall measured and/or estimated unconsolable crying time in the first 3 months (±1 week) of life
Parental stress
Parental stress as measured by the Parental Stress Scale (PSS) at 6 (±1) weeks and 3 months (±1 week) of both (if applicable) caregivers. Parents can indicate the degree to which they agree or disagree with the statements in this questionnaire, ranging from strongly disagree (1 point) to strongly agree (5 points). Total scores range from 18 points (low score signify a low level of stress) to 90 points (high score signify a high level of stress).
Stool consistency
Assessed by the parents in a continuous daily bowel diary over the study period using the Brussels infant and toddler stool scale (BITSS). BITSS was validated as a reliable instrument to assess stools of non-toilet trained children There are 4 possible answers: A: Hard stool, B: Formed stool, C: Loose Stool and D: Watery stool, based on pictures.
Stool frequency
assessed by the parents and day care centers in a continuous daily bowel diary over the study period using the BITSS
Fecal calprotectine levels
Fecal calprotectin at 6 (±1) weeks and 3 months (±1 week) of age
Saliva melatonin levels
Morning saliva melatonin level at 6 (±1) weeks and 3 months (±1 week) of age
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Universitair Ziekenhuis Brussel
Lead sponsor
BioGaia AB
Collaborator
