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

The Archer-Daniels-Midland Company

Status: Enrolling

Conditions: Infantile Colic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432479

PCTB202010

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 3 to 12 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Arm receiving investigation product (probiotic)

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Arm receiving placebo

Treatment:

Dietary Supplement: Placebo