Actively Recruiting
A Randomized, Double-blinded, Placebo-controlled 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
N/A
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
Researchers are evaluating the effectiveness of a single strain probiotic given as a sachet to treat infant colic in babies aged 3 to 12 weeks. The study aims to understand if this probiotic can reduce symptoms like crying and fussing in infants with colic. This is a randomized, double-blinded, placebo-controlled trial sponsored by The Archer-Daniels-Midland Company. Participants will be randomly assigned to one of two groups: one receiving the probiotic supplement containing 1.0E+9 Colony Forming Units daily for 4 weeks, and the other receiving a placebo. The study is designed to compare the probiotic against placebo over a treatment period of 28 days. During the study, parents will record their infant’s crying and fussing times using an electronic diary app, and infants will be monitored for changes in symptoms, sleep time, and use of rescue medications. Visits will occur at the start and end of the 4-week treatment period, with the main measurement focusing on changes in crying and fussing time between Day 0 and Day 28.
CONDITIONS
Brief 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 defined by crying and/or fussing \u22653 hours/day for \u22653 days/week, confirmed with a behaviour diary recording >3 hours of crying in 24 hours.
- Signed informed consent by parent or legal guardian.
- Infant is healthy after physical exam.
- Parents/caregivers willing to comply with trial procedures and mother can attend all three trial visits.
You will not qualify if you...
- Use of antibiotics by the infant within 2 weeks before screening or during run-in period.
- Use of probiotic supplements from birth to enrolment (including probiotic-containing infant formulas).
- Need for hospitalization after initial discharge following delivery.
- Congenital disorders impacting the gastrointestinal tract.
- Failure to thrive.
- Known lactose or gluten intolerance.
- Allergy to cow's milk proteins, fish, or substances in the trial product or placebo.
- Other causes for abdominal pain (e.g., pyloric stenosis).
- Participation in another interventional clinical study.
- Immuno-compromised status or severe chronic disorder.
- 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/parent/caregiver is an employee of the investigational site or Atlantia Clinical Trials or their close family member or household member.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive a daily dose of either the probiotic or placebo for infantile colic symptom relief.
3 visits (baseline, Week 2, and Week 4)
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
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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