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Идёт набор NCT05664113

Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).

Фаза I С лечением Gastro-Intestinal Disorder

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: Fecal microbiota transplant (FMT).
Кому может быть актуально
Состояния в реестре: Gastro-Intestinal Disorder. Базовые параметры: до 22 лет · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT). Primary Objective * To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT. * To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction. Secondary Objectives * To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT. * To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.

Подробное описание

Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT

Вмешательства

  • Препарат Fecal microbiota transplant (FMT)
    FMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube

Первичные конечные точки

  • Proportion of participants with a serious adverse event occurring within 30 days following FMT [Срок оценки: 30 Days]
  • Proportion of participants with a non-serious adverse event occurring within 30 days following FMT [Срок оценки: 30 Days]
  • Proportion of participants expressing interest who meet eligibility [Срок оценки: 2 years]
  • Proportion of participants recruited in the eligible population [Срок оценки: 2 years]
  • Proportion of participants that drop up post-enrollment [Срок оценки: 3 years]
  • Proportion of participants providing all protocol required stool samples [Срок оценки: 3 years]
Вторичные конечные точки (2)
  • Proportion of participants with a complete response or a partial response [Срок оценки: 180 days]
  • Percentage of participants who reduce or discontinue steroids at the end of the study [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age < 22 years old.
  • Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
  • Diagnosed with one of the following conditions:
  • Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, >/= 1mg/kg of prednisolone) OR
  • Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment).

OR

  • Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools >/= 4 weeks with at least one of the following:
  • Requiring NG or G-tube feeds
  • Requiring TPN or IVF for more than 4 weeks
  • Diagnosis of gastroparesis by GI specialist documented in the medical record
  • Willing and able to provide informed assent/consent

Критерии исключения

  • Participant is at risk for aspiration pneumonia
  • History of anaphylactic allergy to foods that are not excluded from the stool donor diet
  • Female participant who is pregnant or nursing
  • History of previous FMT
  • Intra-abdominal surgery within 4 weeks of enrollment
  • At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites
  • Concurrent abdominal radiation therapy
  • Any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • St. Jude Children's Research Hospital — Memphis

Идентификаторы

NCT: NCT05664113 · NEWGUT · NCI-2024-02553

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗