PIXAR: Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Arm receiving investigation product (probiotic) |
Dietary Supplement: Probiotic
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 Comparator: Placebo Arm receiving placebo |
Dietary Supplement: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Change in cry and fuss time [Day 0 , Day 28]
eDiary parent reported cry and fuss time
Secondary Outcome Measures
- Resolution of colic symptoms [Day 0, Day 28]
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
- Change in cry and fuss time bouts [Day 0, Day 28]
eDiary parent reported cry and fuss bouts
- Change in sleeping time [Day 0 Day 28]
eDiary parent reported sleep time
- Change in the use of rescue medications [Day 0, Day 28]
Change in the proportion of participants needing to use rescue medications between the study arms
Other Outcome Measures
- Change in maternal quality of life and mental health [Day 0, Day 28]
Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)
- Change in maternal quality of life and mental health [Day 0, Day 28]
Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Gestational age of minimum 37 weeks.
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Birthweight of minimum 2500 g (5.5 lb.).
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Age of greater than 3 weeks and less than 12 weeks at enrolment.
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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).
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Participant Informed Consent form signed by parent or legal guardian.
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Infant is considered healthy following physical exam.
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Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits
Exclusion Criteria:
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Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
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Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
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Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
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Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
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Failure to thrive.
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Known lactose or gluten intolerance.
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Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
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Known other causes for abdominal pain (e.g., pyloric stenosis).
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Participation in any other interventional clinical study.
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Immuno-compromised participant or participant with other severe chronic disorder.
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Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
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Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Archer-Daniels-Midland Company
- Atlantia Food Clinical Trials
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PCTB202010