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

Infantile Colic Clinical Trial

— PIXAR  

Official title:

A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432479
• Other study ID #: PCTB202010
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: The Archer-Daniels-Midland Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

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
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Archer-Daniels-Midland Company	Atlantia Food Clinical Trials

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in maternal quality of life and mental health	Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)	Day 0, Day 28
Other	Change in maternal quality of life and mental health	Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score)	Day 0, Day 28
Primary	Change in cry and fuss time	eDiary parent reported cry and fuss time	Day 0 , Day 28
Secondary	Resolution of colic symptoms	Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline	Day 0, Day 28
Secondary	Change in cry and fuss time bouts	eDiary parent reported cry and fuss bouts	Day 0, Day 28
Secondary	Change in sleeping time	eDiary parent reported sleep time	Day 0 Day 28
Secondary	Change in the use of rescue medications	Change in the proportion of participants needing to use rescue medications between the study arms	Day 0, Day 28