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 groupsLocations
2Ireland
Atlantia Clinical Trials Cork Ireland
Sweden
Clinical Trail Consultants AB Uppsala Sweden
Sponsors and collaborators
BioGaia AB
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
CTC Clinical Trial Consultants AB
Collaborator
Source ClinicalTrials.gov