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Идёт набор NCT07190859

Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

Без фазы С лечением Infantile Colic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: L. reuteri, Placebo.
Кому может быть актуально
Состояния в реестре: Infantile Colic. Базовые параметры: 3 Weeks — 12 Weeks · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Болгария
Следующий шаг
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Официальное название

A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

Обзор

This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.

Вмешательства

  • Пищевая добавка L. reuteri
    Supplementation with drops containing L. reuteri once daily for 21 consecutive days
  • Пищевая добавка Placebo
    Supplementation with identical drops without L. reuteri once daily for 21 consecutive days

Первичные конечные точки

  • Crying and fussing time [Срок оценки: From baseline to Day 7]
Вторичные конечные точки (5)
  • Crying and fussing time [Срок оценки: From baseline up to Day 21]
  • Number of responders [Срок оценки: From baseline up to Day 21]
  • Family Quality of Life [Срок оценки: From baseline up to Day 21]
  • Sleeping time [Срок оценки: From baseline up to Day 21]
  • Maternal depression [Срок оценки: From baseline up to Day 21]

Критерии участия

Критерии включения

  • Aged between 3-12 weeks at screening.
  • Gestational age 37+0 weeks - 42+0 weeks at birth.
  • Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
  • Parents/caregivers/legal guardians are >18 years.
  • Exclusively or predominantly breastfed infants (> 50 % breast fed).
  • Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
  • Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
  • Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time.
  • Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
  • Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
  • The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
  • Infant is considered healthy, in the opinion of the investigator following physical exam.

Критерии исключения

  • Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
  • Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians.
  • Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
  • Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
  • Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
  • Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.

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

Болгария · 4 центра
  • UMHAT Deva Maria — Burgas
  • Medical Centre Asklepiy OOD — Dupnitsa
  • AIPSMP — Stara Zagora
  • Ipsmp Eood — Stara Zagora

Идентификаторы

NCT: NCT07190859 · CSUB0218

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗