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

A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

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.

Study Overview

• Status: Completed
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: L. reuteri; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • LE
    • Lecce, LE, Italy, 73100
      • University of Salento, University Hospital Vito Fazzi Lecce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 3-12 weeks at screening.
2. Gestational age 37+0 weeks - 42+0 weeks at birth.
3. 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.
4. Parents/caregivers/legal guardians are >18 years.
5. Exclusively or predominantly breastfed infants (> 50 % breast fed).
6. Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
7. Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
8. 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.
9. Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
10. Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
12. Infant is considered healthy, in the opinion of the investigator following physical exam.

Exclusion Criteria:

1. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
2. 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.
3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
4. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
5. Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Supplementation with identical drops without L. reuteri once daily for 21 consecutive days
Experimental: L. reuteri; Dietary Supplement: L. reuteri	Dietary supplement: L. reuteri; Supplementation with drops containing L. reuteri once daily for 21 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying and fussing time	Change in mean daily crying and fussing time measured by Baby´s Day Diary	[Time Frame: From baseline up to Day 21]
Crying time	Change in mean daily crying time measured by Baby´s Day Diary	[Time Frame: From baseline up to Day 21]
Number of responders	Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline	[Time Frame: From baseline up to Day 21]
Family quality of life (family QoL)	Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score	[Time Frame: From baseline up to Day 21]
Sleeping time	Change in mean sleeping time measured by Baby´s Day Diary	[Time Frame: From baseline up to Day 21]
Maternal depression	Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score	[Time Frame: From baseline up to Day 21]

Collaborators and Investigators

• Sponsor: BioGaia AB

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2025
• Primary Completion (Actual): March 15, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colic
• Other Study ID Numbers: CSUB0214 (CSUB0222)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No