Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

Launched by THE ARCHER-DANIELS-MIDLAND COMPANY · Jun 21, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a single strain probiotic, given in a sachet form, is in helping relieve symptoms of infantile colic in babies aged 3 to 12 weeks. Infantile colic is when babies cry or fuss for more than three hours a day for at least three days a week, which can be very challenging for both infants and their parents. The study is currently recruiting participants, and parents or guardians who are interested can sign up if their baby meets certain criteria, such as being born healthy after at least 37 weeks of pregnancy and weighing at least 5.5 pounds.

To participate, parents need to keep a diary of their baby's crying during a trial period to confirm the colic symptoms before enrolling. The trial involves three visits, and parents should be willing to follow the study procedures. However, there are specific reasons that could exclude a baby from joining, such as recent use of antibiotics or certain health conditions. This trial is an opportunity for families looking for potential relief options for their babies' colic symptoms while contributing to valuable research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• • Participant Informed Consent form signed by parent or legal guardian.
• • Infant is considered healthy following physical exam.
• • Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits
• Exclusion Criteria:
• • 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.
• • Failure to thrive.
• • Known lactose or gluten intolerance.
• • Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
• • Known other causes for abdominal pain (e.g., pyloric stenosis).
• • Participation in any other interventional clinical study.
• • Immuno-compromised participant or participant with other severe chronic disorder.
• • Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
• • Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
• • Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.