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

Launched by BIOGAIA AB · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a probiotic called Limosilactobacillus Reuteri (L. Reuteri) on reducing crying and fussing time in infants who have colic. Colic is a common condition in babies characterized by excessive crying, often making both the baby and parents feel stressed. The goal is to see if this probiotic can help soothe the babies and ease their symptoms.

To participate in the study, infants need to be between 3 to 12 weeks old and have been diagnosed with colic, meaning they cry for at least three hours a day for several days in a week. Parents or caregivers must be at least 18 years old and willing to keep track of the baby's crying patterns using a diary provided by the study. It's important that babies are mostly breastfed and have not taken any other medications or probiotics for colic in the week before the study starts. The trial will involve regular check-ins over a few weeks, where parents will answer questions and monitor their baby's progress. This study is not yet recruiting participants, but it aims to provide useful information about managing colic in infants.

Gender

ALL

Eligibility criteria

• 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.