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Набор скоро начнётся NCT07530055

Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome

Без фазы С лечением Short Bowel Syndrome (SBS)

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: collection of blood and stool/chyme and intestinal biopsy.
Кому может быть актуально
Состояния в реестре: Short Bowel Syndrome (SBS). Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome: a Longitudinal Follow-up

Обзор

During the first years following intestinal resection, spontaneous physiological adaptations occur in patients with short bowel syndrome (SBS), allowing improvement of the absorptive capacity of the remaining intestine. This adaptation is particularly effective in SBS patients with the colon in continuity. The specific relationship between this intestinal adaptation and changes in the gut microbiota has not been studied in these patients. We hypothesize that there is a specific relationship between the microbiota and its metabolites and intestinal adaptive capacity, and that certain gut bacteria may promote this spontaneous adaptation.

Подробное описание

We know that spontaneous adaptation, including weaning from parenteral nutrition, is more likely in patients with short bowel syndrome (SBS) who have the colon in continuity. However, the underlying mechanisms remain unclear. We have shown that the gut microbiota is altered in patients with SBS, with an overabundance of lactic acid bacteria (bacteria responsible for fermentation). It is therefore possible that some of these bacteria may promote spontaneous adaptation and improved absorption in patients with SBS with a colon in continuity, thereby enabling weaning from parenteral nutrition.

In the proposed research, we will study changes in the composition of the gut microbiota in adults with SBS before and at the beginning of the restoration of colonic continuity within the digestive tract (new type 2 SBS patients). To this end, we will compare changes in fecal bacterial populations with the intestine's capacity to adapt and absorb nutrients.

This will make it possible to identify specific factors within the microbiota or in the substances they produce (microbial biomarkers) that could become future targets for improving energy absorption. To address the research question, it is planned to include 15 individuals with SBS, followed in the gastroenterology and nutritional support department at Beaujon Hospital in Clichy

Primary Objective:

To study the relationship between intestinal absorptive capacity in adults with type 2 short bowel syndrome (jejuno-colic anastomosis) and the composition of the fecal microbiota after the restoration of colonic continuity.

Вмешательства

  • Другое collection of blood and stool/chyme and intestinal biopsy
    The only procedures added by the study are the collection of an additional volume of blood and stool/chyme during samples taken as part of routine care, as well as an intestinal biopsy

Первичные конечные точки

  • Correlation between intestinal absorptive capacity in adults with type 2 short bowel syndrome after restoration of digestive continuity and changes in the fecal microbiota [Срок оценки: from inclusion until 12 months post surgery]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Diagnosis of short bowel syndrome with a jejunostomy and a plan to restore jejuno-colic continuity within 3 months
  • Remaining post-duodenal small intestine (after the ligament of Treitz) < 200 cm
  • Remaining colon > 14%
  • Remaining small intestine and colon are healthy (no residual inflammatory, post-radiation, or ischemic disease)
  • Patient enrolled in a social security system or entitled to coverage

Критерии исключения

  • Pregnancy
  • Patient unable to provide consent:
  • Due to a disability preventing consent
  • Does not understand French
  • Patient deprived of liberty, or under legal protection (guardianship or curatorship)
  • Participation in another interventional study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07530055 · APHP221024 · IDRCB: 2025-A01399-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗