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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
L. reuteri
Dietary supplementDietary supplementation with drops containing L. reuteri once daily for 21 consecutive days
Placebo
Dietary supplementDietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: L. reuteriExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Crying and fussing time
Change in daily crying and fussing time measured by Baby Day Diary
Time frame
From baseline to Day 7Secondary outcomes
1
Crying and fussing time
Change in mean daily crying and fussing time measured by Baby Day Diary
Time frame
From baseline to Day 3, Day 5, Day 14, Day 212
Crying time
Change in mean daily crying time measured by Baby Day Diary
Time frame
From baseline to Day 3, Day 5, Day 7, Day 14, Day 213
Number of responders
Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline
Time frame
From baseline to Day 3, Day 5, Day 7, Day 14, Day 214
Family quality of life (family QoL)
Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score
Time frame
From baseline to Day 7 and Day 21Sponsors and contacts
Click on the lead sponsor to view all of their trials.
BioGaia AB
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
CTC Clinical Trial Consultants AB
Collaborator
Source ClinicalTrials.gov