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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infantile Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Arm receiving investigation product (probiotic)

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Arm receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

3 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No