Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.

NCT07347743 | Recruiting DMC

• 1 other identifier: Prot-Prev
• Study Type: interventional
• Target: 768
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colic; Healthy Infants; Eczema Atopic Dermatitis

Keywords

Preventive effect; Limosilactobacillus reuteri; L. reuteri; crying; colic; healthy infants; newborns

Outcome Measures

Primary Outcomes (2)

• Peak measured crying time

  Peak measured crying time at 6 (±1) weeks according to the prospectively kept baby day diary

  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.

  3 months

Secondary Outcomes (7)

• Peak measured fussiness time

  6 weeks

• Overall crying and/or fussiness time

  3 months

• Overall unconsolable crying time

  3 months

• Parental stress

  3 months

• Quality of Life score

  12 months

Other Outcomes (12)

• Stool consistency

  3 months

• Stool frequency

  3 months

• Fecal calprotectine levels

  3 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

The control groups gets no Limosilactobacillus reuteri

Dietary Supplement: Placebo

Intervention group

EXPERIMENTAL

The intervention group gets the two probiotic Limosilactobacillus reuteri strains

Dietary Supplement: Two probiotic Limosilactobacillus reuteri strains

Interventions

Two probiotic Limosilactobacillus reuteri strains DIETARY_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

Intervention group

Placebo DIETARY_SUPPLEMENT

Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.

Control group

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioGaia AB: collaborator
• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Colic; Crying

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nonverbal Communication; Communication; Behavior

Study Officials

• Koen Huysentruyt, Pediatric Gastroenterologist

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Huysentruyt, Pediatric Gastroenterologist

CONTACT

+32 02/476.37.17; koen.huysentruyt@uzbrussel.be

Leontien Depoorter, Resident Pediatric Pulmonology

CONTACT

+32 02/801.25.58; Leontien.Depoorter@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, double-blind, parallel, randomized, placebo-controlled superiority trial.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 16, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2025-10

Locations

BE (1)