Actively Recruiting
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Led by The Archer-Daniels-Midland Company · Updated on 2025-04-09
80
Participants Needed
2
Research Sites
187 weeks
Total Duration
On this page
Sponsors
T
The Archer-Daniels-Midland Company
Lead Sponsor
A
Atlantia Food Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age of minimum 37 weeks
- Birthweight of minimum 2500 g (5.5 lb.)
- Age greater than 3 weeks and less than 12 weeks at enrolment
- Confirmed infantile colic with crying and/or fussing 3 or more hours/day for 3 or more days/week, confirmed by infant behaviour diary
- Signed informed consent by parent or legal guardian
- Infant is healthy based on physical exam
- Parents/caregivers willing to follow trial procedures and able to attend all three trial visits
You will not qualify if you...
- Infant use of antibiotics within 2 weeks before screening or during run-in period
- Use of probiotic supplements by infant from birth to enrolment, including formulas with probiotics
- Need for hospitalization after initial delivery discharge
- Congenital disorders affecting the gastrointestinal tract
- Failure to thrive
- Known lactose or gluten intolerance
- Known allergy to cow's milk proteins, fish, or trial product substances
- Other known causes for abdominal pain such as pyloric stenosis
- Participation in other interventional clinical studies
- Immuno-compromised status or severe chronic disorders
- Use of probiotic supplements by breastfeeding mother from birth to enrolment
- Use of antibiotics by breastfeeding mother within 2 weeks before screening or during run-in period
- Participant or caregiver employed by investigational site or Atlantia Clinical Trials or close family member or household member
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Atlantia Food Clinical Trials
Chicago, Illinois, United States, 60611
Completed
2
Pulse Multispeciality Hospital,
Pune, Maharashtra, India, Pune 411 041
Actively Recruiting
Research Team
A
ADM Medical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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