Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
ConditionInfantile Colic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorThe Archer-Daniels-Midland Company
About this trial
This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gestational age of minimum 37 weeks.
Birthweight of minimum 2500 g (5.5 lb.).
Age of greater than 3 weeks and less than 12 weeks at enrolment.
Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording >3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period & for duration of study).
Disqualifiers
Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementSingle strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks
Placebo
Dietary supplementPlacebo
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in cry and fuss time
eDiary parent reported cry and fuss time
Time frame
Day 0 , Day 28Secondary outcomes
1
Resolution of colic symptoms
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Time frame
Day 0, Day 282
Change in cry and fuss time bouts
eDiary parent reported cry and fuss bouts
Time frame
Day 0, Day 283
Change in sleeping time
eDiary parent reported sleep time
Time frame
Day 0 Day 284
Change in the use of rescue medications
Change in the proportion of participants needing to use rescue medications between the study arms
Time frame
Day 0, Day 28Other outcomes
1
Change in maternal quality of life and mental health
Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)
Time frame
Day 0, Day 282
Change in maternal quality of life and mental health
Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score)
Time frame
Day 0, Day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Archer-Daniels-Midland Company
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Vedic Lifesciences Pvt. Ltd.
Collaborator
Source ClinicalTrials.gov