Evaluating a Probiotic for Relief of Infantile Colic Symptoms
A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
This study is testing if a special probiotic can help babies aged 3 to 12 weeks with colic cry less and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 3 Weeks to 12 Weeks |
| Sex | All |
| Sponsor | The Archer-Daniels-Midland Company Industry-sponsored |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05432479 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of a single strain probiotic administered in sachet form for treating infantile colic in infants aged 3 to 12 weeks. The trial involves a randomized, controlled design where infants will receive either the probiotic or a placebo. Parents will document their infants' crying and fussing behaviors using an eDiary app to confirm the presence of colic symptoms. The study aims to determine if the probiotic can significantly reduce the duration of crying episodes in affected infants.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged 3 to 12 weeks who exhibit symptoms of infantile colic.
Not a fit: Patients who have used antibiotics or probiotic supplements recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safe and effective option for alleviating colic symptoms in infants, improving their quality of life and that of their families.
How similar studies have performed: Other studies have shown promising results with probiotics for gastrointestinal issues in infants, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois and 1 other locations
- Atlantia Food Clinical Trials — Chicago, Illinois, United States (Completed)
- Pulse Multispeciality Hospital, — Pune, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: ADM Medical Team
- Email: medical@protexin.com
- Phone: +44 1460 243 230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.