Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

NCT07190859 | Recruiting

• 1 other identifier: CSUB0218
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

• Crying and fussing time

  Change in mean crying and fussing time as assessed by the Baby's Day Diary

  From baseline to Day 7

Secondary Outcomes (5)

• Crying and fussing time

  From baseline up to Day 21

• Number of responders

  From baseline up to Day 21

• Family Quality of Life

  From baseline up to Day 21

• Sleeping time

  From baseline up to Day 21

• Maternal depression

  From baseline up to Day 21

Study Arms (2)

L. reuteri

EXPERIMENTAL

Dietary supplement: L. reuteri

Dietary Supplement: L. reuteri

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

L. reuteri DIETARY_SUPPLEMENT

Supplementation with drops containing L. reuteri once daily for 21 consecutive days

L. reuteri

Placebo DIETARY_SUPPLEMENT

Supplementation with identical drops without L. reuteri once daily for 21 consecutive days

Placebo

Eligibility Criteria

• Age: 3 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 3-12 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.
• The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
• Infant is considered healthy, in the opinion of the investigator following physical exam.

You may not qualify if:

• Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis).
• Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians.
• Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
• Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
• Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
• Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.

Sponsors & Collaborators

• BioGaia AB: lead

Study Sites (4)

UMHAT Deva Maria

Burgas, 8127, Bulgaria

RECRUITING

Medical Centre Asklepiy OOD

Dupnitsa, 2600, Bulgaria

RECRUITING

AIPSMP

Stara Zagora, 6000, Bulgaria

RECRUITING

Ipsmp Eood

Stara Zagora, 6000, Bulgaria

RECRUITING

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sanna Nyström, PhD

CONTACT

+46761483866; sny@biogaia.se

Petra J Lierud

CONTACT

+46724504400; pjl@biogaia.se

Study Design

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

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: August 4, 2025
• Primary Completion: February 17, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

BU (4)