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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
The Archer-Daniels-Midland Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic focused on measuring probiotic, Bifidobacterium

Eligibility Criteria

3 Weeks - 12 Weeks (Child)All SexesDoes not accept 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.

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

    First Posted
    June 21, 2022
    Last Updated
    June 27, 2022
    Sponsor
    The Archer-Daniels-Midland Company
    Collaborators
    Atlantia Food Clinical Trials
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    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

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

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