Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
ConditionColic, Infantile
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorBioGaia AB
About this trial
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.
Eligibility criteria
Qualifiers
Aged between 3-8 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- L. reuteri
- Placebo
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
BioGaia AB
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
CTC Clinical Trial Consultants AB
Collaborator
Source ClinicalTrials.gov