Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief (PIXAR)
Primary Purpose
Infantile Colic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Colic focused on measuring probiotic, Bifidobacterium
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Arm receiving investigation product (probiotic)
Arm receiving placebo
Outcomes
Primary Outcome Measures
Change in cry and fuss time
eDiary parent reported cry and fuss time
Secondary Outcome Measures
Resolution of colic symptoms
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Change in cry and fuss time bouts
eDiary parent reported cry and fuss bouts
Change in sleeping time
eDiary parent reported sleep time
Change in the use of rescue medications
Change in the proportion of participants needing to use rescue medications between the study arms
Full Information
NCT ID
NCT05432479
First Posted
June 21, 2022
Last Updated
June 27, 2022
Sponsor
The Archer-Daniels-Midland Company
Collaborators
Atlantia Food Clinical Trials
1. Study Identification
Unique Protocol Identification Number
NCT05432479
Brief Title
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Acronym
PIXAR
Official Title
A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Archer-Daniels-Midland Company
Collaborators
Atlantia Food Clinical Trials
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
Keywords
probiotic, Bifidobacterium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Arm receiving investigation product (probiotic)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm receiving placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in cry and fuss time
Description
eDiary parent reported cry and fuss time
Time Frame
Day 0 , Day 28
Secondary Outcome Measure Information:
Title
Resolution of colic symptoms
Description
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Time Frame
Day 0, Day 28
Title
Change in cry and fuss time bouts
Description
eDiary parent reported cry and fuss bouts
Time Frame
Day 0, Day 28
Title
Change in sleeping time
Description
eDiary parent reported sleep time
Time Frame
Day 0 Day 28
Title
Change in the use of rescue medications
Description
Change in the proportion of participants needing to use rescue medications between the study arms
Time Frame
Day 0, Day 28
Other Pre-specified Outcome Measures:
Title
Change in maternal quality of life and mental health
Description
Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)
Time Frame
Day 0, Day 28
Title
Change in maternal quality of life and mental health
Description
Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score)
Time Frame
Day 0, Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
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