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
Qualifiers
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
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Archer-Daniels-Midland Company
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Vedic Lifesciences Pvt. Ltd.
Collaborator
Source ClinicalTrials.gov