An interventional study of Two probiotic Limosilactobacillus reuteri strains and Placebo in Colic, Healthy Infants and Eczema Atopic Dermatitis, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to participants aged 1 Day to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Prevention
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.
This study is a double-blind, randomized, placebo-controlled trial conducted at UZ Brussel to evaluate the safety and preventive efficacy of a dietary supplement containing two probiotic strains of Limosilactobacillus reuteri on excessive crying and the development of infantile colic in healthy newborns.
Recent systematic reviews and meta-analyses have shown that supplementation with certain strains of L. reuteri significantly reduces crying and fussing time in infants. A novel formulation combining those strains was developed to achieve a potentially enhanced effect on infant distress symptoms. This study investigates whether early supplementation, initiated within the first week of life, is safe and effective during the first three months of life.
Healthy, full-term infants (≥37 weeks' gestation) aged 1-14 days at inclusion are eligible. Participants are randomized to receive either placebo plus vitamin D (400 IU) or L. reuteri plus vitamin D (400 IU) for a maximum of 98 days, until approximately 3 months of age.
Study visits include a baseline visit (day 1-14), a midway visit at 6 weeks, an end-of-intervention visit at 3 months, and a long-term follow-up at 1 year. Additional telephone contacts are triggered by infant day diaries.
The primary outcomes are peak crying and fussing time at 6 weeks of age and the occurrence of infantile colic during the first 3 months of life. Secondary outcomes include infant quality of life (ITQOL™), parental stress, parental satisfaction, crying and fussiness patterns, and the presence of atopic dermatitis. Exploratory outcomes assess changes in the intestinal microbiome, stool characteristics, biomarkers, growth, and allergy-related parameters.
The primary hypothesis is that daily supplementation with the two strains of L. reuteri reduces the incidence of infantile colic and peak crying time at 6 weeks. Secondary hypotheses propose microbiome modulation leading to reduced distress, improved infant quality of life, and lower parental stress.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's planned enrollment of 768 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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Exclusion Criteria:
The control groups gets no Limosilactobacillus reuteri
Dietary Supplement: Placebo
The intervention group gets the two probiotic Limosilactobacillus reuteri strains
Dietary Supplement: Two probiotic Limosilactobacillus reuteri strains
Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
Each 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
Time frame: 6 weeks
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.
Time frame: 3 months
Peak measured fussiness time
Peak measured fussiness time at the age of 6 (±1) weeks according to the prospectively kept baby day diary.
Time frame: 6 weeks
Overall crying and/or fussiness time
Overall (estimated + measured) crying and/or fussiness time in the first 3 months (±1 week) of life.
Time frame: 3 months
Overall unconsolable crying time
Overall measured and/or estimated unconsolable crying time in the first 3 months (±1 week) of life
Time frame: 3 months
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).
Time frame: 3 months
Quality of Life score
Infant and toddler quality of life questionnaire(ITQOL™) at 3 months (±1 week) and of 12 months (±2 weeks) age. ITQOL is scored on a scale from 0 to 100, where higher scores mean better health/quality of life.
Time frame: 12 months
Parental satisfaction
Parental satisfaction scale measured by a 5-point Likert scale at 6 (±1) weeks and 3 months (±1 week). A scale where parents indicate how satisfied they are with their baby's current level of crying and fussing, with a minimum score of 2 and maximum score of 10. Parents who are very dissatisfied have a low score, while parents who are very satisfied have a high score.
Time frame: 3 months
Atopic dermatitis
Presence and degree of atopic dermatitis (AD, measured via SCORAD) at 3 months (±1 week) and 12 months (±2 weeks) of age. The score ranges from 0 to 103 and is used to determine the stages of AD severity. Where a score lower than 25 is seen as mild state, 25-50 is a moderate state and \>50 is a severe state.
Time frame: 12 months
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.
Time frame: 3 months
Stool frequency
assessed by the parents and day care centers in a continuous daily bowel diary over the study period using the BITSS
Time frame: 3 months
Fecal calprotectine levels
Fecal calprotectin at 6 (±1) weeks and 3 months (±1 week) of age
Time frame: 3 months
Saliva melatonin levels
Morning saliva melatonin level at 6 (±1) weeks and 3 months (±1 week) of age
Time frame: 3 months
Safety outcomes - Adverse events
Number of (serious) adverse events throughout the study period. Parents are asked to provide detailed information on any adverse events their child may experience during the study. For each event, the diagnosis, sign, or symptom is written down, as well as the date the event started and ended. Parents should also describe the severity of the event, rating it as mild, moderate, or severe, and provide their assessment of its relationship to the study product, categorizing it as unrelated, unlikely, probable, or related. Moreover the outcome of the event should be specified, such as fatal, not resolved, resolved, resolved with sequelae, resolving, or unknown. Lastly, parents should report any actions taken regarding the study product, including whether the dose was unchanged, reduced, increased, temporarily suspended, or definitively withdrawn, or if there was any concomitant medication given to the child or no action was required.
Time frame: 3 months
Weight
Weight for age z score at each study visit
Time frame: 3 months
Stool pH
Stool pH at 6 (±1) weeks and 3 months (±1 week)
Time frame: 3 months
Short Chain Fatty Acids (SCFA)
SCFA analysis at 6 (±1) weeks and 3 months (±1 week) of age. Concentrations of both straight-chain SCFA as branched-chain SCFA will be measured to be associated with the health status of the gut microbiota.
Time frame: 3 months
Skin microbiome
16S ribosomal RNA (rRNA) gene amplicon sequencing of skin microbiome (or shotgun metagenomics sequencing if the budget allows for this) at 6 weeks, 3 months and 12 months. To gain insight into the quantitative and qualitative abundance of microbial composition and diversity
Time frame: 12 months
Stool microbiome
16S ribosomal RNA (rRNA) gene amplicon sequencing of stool microbiome (or shotgun metagenomics sequencing if the budget allows for this) at 6 weeks, 3 months. To gain insight into the quantitative and qualitative abundance of microbial composition and diversity
Time frame: 3 months
Height
Height for age Z-score at each study visit
Time frame: 3 months
Weight for height
Weight for height z score at each study visit
Time frame: 3 months
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