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

Study Overview
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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.

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

Conditions
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Infantile Colic

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Arm receiving investigation product (probiotic) | Dietary Supplement: Probiotic<br>* 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<br>|
| Placebo Comparator: Placebo<br>Arm receiving placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cry and fuss time | eDiary parent reported cry and fuss time | Day 0 , Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of colic symptoms | Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline | Day 0, Day 28 | 
| Change in cry and fuss time bouts | eDiary parent reported cry and fuss bouts | Day 0, Day 28 | 
| Change in sleeping time | eDiary parent reported sleep time | Day 0 Day 28 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, Bifidobacterium