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Идёт набор NCT06385054

Effect of Probiotics on Infantile Colic Symptoms

Фаза II 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: Probiotic, Placebo.
Кому может быть актуально
Состояния в реестре: Infantile Colic. Базовые параметры: до 8 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
Франция
Следующий шаг
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Официальное название

Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).

Обзор

The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.

Подробное описание

The goal of this clinical trial is to evaluate the potential beneficial effects of B. lactis B94 on the symptoms of infantile colic.

Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.

The study will consist of 3 in-person visits and 4 phone calls.

Вмешательства

  • Пищевая добавка Probiotic
    Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
  • Пищевая добавка Placebo
    Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.

Первичные конечные точки

  • Change in daily crying duration [Срок оценки: 4 weeks]
Вторичные конечные точки (6)
  • Change in crying patterns [Срок оценки: 4 weeks]
  • Change in sleep duration [Срок оценки: 4 weeks]
  • Change in maternal quality of life [Срок оценки: 4 weeks]
  • Change in bowel habits [Срок оценки: 4 weeks]
  • Change in gut microbiota composition [Срок оценки: 4 weeks]
  • Probiotic strain recovery [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.

I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.

I5. With a written informed consent signed by the father and mother or legal guardian.

I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.

I7. At least one of the legal representatives is affiliated with a social security scheme.

Критерии исключения

E1. Birthweight < 2500 g. E2. Gestational age < 37 weeks. E3. Apgar score at 5 minutes < 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.

E5. Stunted growth/weight loss (< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.

E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.

E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.

E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.

E15. Use of anti-colic medication at any time from birth to the moment of screening.

E16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.

E17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.

E18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.

E19. Impossibility to contact the legal representatives in case of emergency.

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
Поддерживающая терапия

Центры проведения

Франция · 10 центров
  • Cabinet privé Dr Regimbart-Trubuil Christine — Bécon-les-Granits
  • Centre Hospitalier de Boulogne-sur-Mer — Boulogne-sur-Mer
  • CHU Caen Normandie — Caen
  • CHU Grenoble Alpes — La Tronche
  • Hôpital Saint Vincent de Paul — Lille
  • Centre Hospitalier de Montauban — Montauban
  • CHU de NANTES — Nantes
  • Biofortis, Unité d'investigation Clinique — Paris
  • … и ещё 2 центра

Идентификаторы

NCT: NCT06385054 · L-027 · 2023-A02612-43 · PEC23063

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗