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

NCT06462651 | Completed

• 1 other identifier: CSUB0214 (CSUB0222)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

  To evaluate crying and fussing time after 7 days of supplementation with L. reuteri in infants with colic.

  [Time Frame: From baseline to Day 7]

Secondary Outcomes (6)

• Crying and fussing time

  [Time Frame: From baseline up to Day 21]

• Crying time

  [Time Frame: From baseline up to Day 21]

• Number of responders

  [Time Frame: From baseline up to Day 21]

• Family quality of life (family QoL)

  [Time Frame: From baseline up to Day 21]

• Sleeping time

  [Time Frame: From baseline up to Day 21]

Study Arms (2)

L. reuteri

EXPERIMENTAL

Dietary Supplement: L. reuteri

Dietary Supplement: L. reuteri

Placebo

PLACEBO COMPARATOR

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 (1)

University of Salento, University Hospital Vito Fazzi Lecce

Lecce, LE, 73100, Italy

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

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: June 12, 2024
• First Posted: June 17, 2024
• Study Start: June 9, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

IT (1)