ColicProtectPreventNCT07347743
Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
A study testing Two probiotic Limosilactobacillus reuteri strains in people with Colic and Healthy Infants, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Colic, Healthy Infants, Eczema Atopic Dermatitis
- What is being tested?
- Two probiotic Limosilactobacillus reuteri strains
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 768 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- Infant is suitable for participation in the study according to the investigator/ study personnel
- Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
- Informed written consent given by parent / legal guardian
Who cannot join
- 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
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leontien Depoorter, Resident Pediatric Pulmonology contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
About this study
Official title: Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
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.
Read the detailed description
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.
- Conditions
- Colic, Healthy Infants, Eczema Atopic Dermatitis
- Being tested
- Two probiotic Limosilactobacillus reuteri strains, Placebo
- Keywords
- Preventive effect, Limosilactobacillus reuteri, L. reuteri, crying, colic, healthy infants, newborns
- Medical subject headings
- Colic, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two probiotic Limosilactobacillus reuteri strainsDietary supplement
Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
PlaceboDietary supplement
Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control groups gets no Limosilactobacillus reuteri Receives: Dietary Supplement: Placebo |
| Intervention group | Experimental | The intervention group gets the two probiotic Limosilactobacillus reuteri strains Receives: Dietary Supplement: Two probiotic Limosilactobacillus reuteri strains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak measured crying time
Peak measured crying time at 6 (±1) weeks according to the prospectively kept baby day diary
Measured: 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.
Measured: 3 months
Secondary outcomes (7)
Peak measured fussiness time
Peak measured fussiness time at the age of 6 (±1) weeks according to the prospectively kept baby day diary.
Measured: 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.
Measured: 3 months
Overall unconsolable crying time
Overall measured and/or estimated unconsolable crying time in the first 3 months (±1 week) of life
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start31 Jan 2026
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColicStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blind, parallel, randomized, placebo-controlled superiority trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Sponsor
- Investigators
- Koen Huysentruyt, Pediatric Gastroenterologist, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347743
- Sponsor's protocol ID
- Prot-Prev
- Acronym
- ProtectPrevent
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
- ClinicalTrials.gov ID
- NCT07347743
- Acronym / sponsor ID
- ProtectPrevent / Prot-Prev
- Conditions
- Colic, Healthy Infants, Eczema Atopic Dermatitis
- Keywords
- Preventive effect, Limosilactobacillus reuteri, L. reuteri, crying, colic, healthy infants, newborns
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blind, parallel, randomized, placebo-controlled superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: PlaceboThe control groups gets no Limosilactobacillus reuteri |
| Intervention group | Experimental | Dietary Supplement: Two probiotic Limosilactobacillus reuteri strainsThe intervention group gets the two probiotic Limosilactobacillus reuteri strains |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- Infant is suitable for participation in the study according to the investigator/ study personnel
Key exclusion criteria (6 listed)
- 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
- Infant is admitted post-partum to the neonatal intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two probiotic Limosilactobacillus reuteri strainsEach participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D | Dietary supplement | Intervention group |
| PlaceboEach participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D. | Dietary supplement | Control group |
Primary outcome
Peak measured crying time
Time frame: 6 weeks
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.
Time frame: 3 months
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.
7 secondary outcomes
Peak measured fussiness time
Time frame: 6 weeks
Overall crying and/or fussiness time
Time frame: 3 months
Overall unconsolable crying time
Time frame: 3 months
Parental stress
Time frame: 3 months
Quality of Life score
Time frame: 12 months
Parental satisfaction
Time frame: 3 months
Atopic dermatitis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leontien Depoorter, Resident Pediatric Pulmonology contact
Koen Huysentruyt, Pediatric Gastroenterologist principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two probiotic Limosilactobacillus reuteri strains in people with Colic and Healthy Infants, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koen Huysentruyt, Pediatric Gastroenterologist (+32 02/476.37.17, koen.huysentruyt@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak measured crying time (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.