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

NCT ID: NCT05512234

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2025-10-30

Brief Summary

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

Detailed Description

Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers.

Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.

Conditions

Colic, Infantile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

L. reuteri

5 drops administered once daily for 21 days

Group Type: EXPERIMENTAL

L. reuteri

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

5 drops administered once daily for 21 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days

Interventions

L. reuteri

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Aged between 3-8 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 4 (Day 8), and Visit 6 (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.

• Minimum Eligible Age: 3 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

CTC Clinical Trial Consultants AB

INDUSTRY

Sponsor Role: collaborator

BioGaia AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenny Palming, PhD

Role: STUDY_DIRECTOR

BioGaia AB

Locations

Atlantia Clinical Trials

Cork, , Ireland

Site Status: RECRUITING

Clinical Trail Consultants AB

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Ireland; Sweden

Central Contacts

Caroline Linninge, PhD

Role: CONTACT

cli@biogaia.se

+46 703811942

Facility Contacts

Aisling Harrington

Role: primary

Kristina Ocklind

Role: primary

Other Identifiers

CSUB0197

Identifier Type: -

Identifier Source: org_study_id