NCT05432479 · The Archer-Daniels-Midland Company
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
(PIXAR)
What this study is about
This study evaluates the effectiveness of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2025 · Source of record for eligibility and locations