Clinical trial NCT05432479: Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infantile Colic
Keywords: probiotic
Bifidobacterium
colic
cry
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
name: Vedic Lifesciences Pvt. Ltd.
First posted: 2022-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in cry and fuss time
timeFrame: Day 0 , Day 28
Secondary outcomes:
measure: Resolution of colic symptoms
timeFrame: Day 0, Day 28
measure: Change in cry and fuss time bouts
timeFrame: Day 0, Day 28
measure: Change in sleeping time
timeFrame: Day 0 Day 28
measure: Change in the use of rescue medications
timeFrame: Day 0, Day 28
Other outcomes:
measure: Change in maternal quality of life and mental health
timeFrame: Day 0, Day 28
measure: Change in maternal quality of life and mental health
timeFrame: Day 0, Day 28
Locations:
city: Chicago
country: United States
facility: Atlantia Food Clinical Trials
state: Illinois
city: Pune
country: India
facility: Pulse Multispeciality Hospital,
state: Maharashtra
Study officials:
References: