Infantile Colic
Conditions
Keywords
probiotic, Bifidobacterium, colic, cry
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Atlantia Food Clinical Trials
Vedic Lifesciences Pvt. Ltd.
The Archer-Daniels-Midland Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 12 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cry and fuss time | Day 0 , Day 28 | eDiary parent reported cry and fuss time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of colic symptoms | Day 0, Day 28 | Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline |
| Change in cry and fuss time bouts | Day 0, Day 28 | eDiary parent reported cry and fuss bouts |
| Change in sleeping time | Day 0 Day 28 | eDiary parent reported sleep time |
| Change in the use of rescue medications | Day 0, Day 28 | Change in the proportion of participants needing to use rescue medications between the study arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in maternal quality of life and mental health | Day 0, Day 28 | Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score) |
Countries
India, United States
Contacts
Primary ContactADM Medical Team
Outcome results
None listed