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Ltd.","100472484","study-to-evaluate-the-efficacy-of-a-probiotic-in-infantile-colic-symptoms-relief-100472484",false,"NCT05432479","Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief","A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief","PIXAR","Inclusion Criteria:\n\n* Gestational age of minimum 37 weeks.\n* Birthweight of minimum 2500 g (5.5 lb.).\n* Age of greater than 3 weeks and less than 12 weeks at enrolment.\n* Confirmed Infantile colic defined as: parental report of crying and\u002For fussing ≥3 hours\u002Fday for ≥3 days\u002Fweek, 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).\n* Participant Informed Consent form signed by parent or legal guardian.\n* Infant is considered healthy following physical exam.\n* Parents\u002FCaregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits\n\nExclusion Criteria:\n\n* Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.\n* Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).\n* Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).\n* Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.\n* Failure to thrive.\n* Known lactose or gluten intolerance.\n* Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.\n* Known other causes for abdominal pain (e.g., pyloric stenosis).\n* Participation in any other interventional clinical study.\n* Immuno-compromised participant or participant with other severe chronic disorder.\n* Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.\n* Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.\n* Any Participant\u002FParent\u002FCaregiver 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.","ALL","3 Weeks","12 Weeks",{"count":86,"type":87},80,"ESTIMATED","INTERVENTIONAL",[90],"NA","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.",[93],"Infantile Colic",[95,96,97,98],"probiotic","Bifidobacterium","colic","cry","2025-04-08",{"date":101,"type":102},"2025-04-09","ACTUAL",{"date":104,"type":102},"2022-09-30",{"date":106,"type":87},"2026-05",{"name":5,"class":6},2]