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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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
• Пищевая добавка Placebo
  Placebo

Первичные конечные точки

• Change in cry and fuss time [Срок оценки: Day 0 , Day 28]

Вторичные конечные точки (4)

• Resolution of colic symptoms [Срок оценки: Day 0, Day 28]
• Change in cry and fuss time bouts [Срок оценки: Day 0, Day 28]
• Change in sleeping time [Срок оценки: Day 0 Day 28]
• Change in the use of rescue medications [Срок оценки: Day 0, Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Atlantia Food Clinical Trials — Chicago

Индия · 1 центр

• Pulse Multispeciality Hospital, — Pune

Идентификаторы

NCT: NCT05432479 · PCTB202010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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