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

Not Applicable

Not yet recruiting

• Conditions: Infantile Colic
• Interventions: Dietary Supplement: L. reuteri; Dietary Supplement: Placebo

• Registration Number: NCT06462651
• Lead Sponsor: BioGaia AB

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Study Start: 2024-10
• Primary Completion: 2025-06
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L. reuteri	L. reuteri	Dietary Supplement: L. reuteri
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Crying and fussing time	[Time Frame: From baseline to Day 7]	To evaluate crying and fussing time after 7 days of supplementation with L. reuteri in infants with colic.

Secondary Outcome Measures

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