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

Part of paid clinical trials in Chicago, Illinois.

Sponsor: The Archer-Daniels-Midland Company
Study ID: NCT05432479
Status: Recruiting

Apply to this trial

Conditions

Infantile Colic

Eligibility Criteria

Sex: ALL
Age: 3 Weeks - 12 Weeks
Healthy Volunteers: Not accepted

Interventions

Probiotic — DIETARY_SUPPLEMENT
Single strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks
Placebo — DIETARY_SUPPLEMENT
Placebo

Study Details

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.

Key Dates

Start date: Sep 30, 2022
Status verified: Apr 2025
Primary completion: May 31, 2026
Completion: May 31, 2026

Study Design

Enrollment: 80 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Active
Arm receiving investigation product (probiotic)
Placebo Comparator: Placebo
Arm receiving placebo

Primary Outcome Measure

Change in cry and fuss time [ Time Frame: Day 0 , Day 28 ]

Central Contacts

ADM Medical Team
+44 1460 243 230
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Atlantia Food Clinical Trials	Chicago	Illinois	60611	-

Find similar trials in Chicago, IL

By research site

Atlantia Food Clinical Trials· Chicago, IL