Меню
Идёт набор NCT06903806

Microbiome Sampling During Endurance Exercise

Без фазы С лечением Healthy Exercise-Induced Lactic Acidemia

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: Treadmill Exercise, Cooling Gloves, Microbiome Capsule.
Кому может быть актуально
Состояния в реестре: Healthy, Exercise-Induced Lactic Acidemia. Базовые параметры: 18 лет — 80 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Determination of Microbiome Diversity and Inflammation Throughout the GI Tract During Endurance Exercise

Обзор

The small intestine and feces of subjects undergoing endurance exercise will be sampled to examine their microbiome composition

Подробное описание

The close relationship between humans and the commensal microbes of their gut microbiota represents vast potential for health maintenance, but most efforts have been focused on disease. Gastrointestinal (GI) problems are very common especially in endurance athletes, and are known to impair performance or subsequent recovery. Moreover, GI symptoms among athletes vary enormously, and some athletes are more prone than others; the links between this variation and the differences in microbiome composition across individuals have not been elucidated. The investigators propose to use a novel, non-invasive sampling technology to quantify the effects of exercise on the GI environment including the small intestines, and aim to establish the potential for dietary interventions to improve recovery from exercise.

Вмешательства

  • Другое Treadmill Exercise
    Participants perform moderate to strenuous exercise for up to 20 minutes on a treadmill after swallowing a microbiome sampling capsule.
  • Устройство Cooling Gloves
    Cooling gloves to prevent rise in core body temperature during exercise
  • Устройство Microbiome Capsule
    Capsule used for collecting intestinal tract contents

Первичные конечные точки

  • Number of participants completing exercise [Срок оценки: 1 day]
Вторичные конечные точки (1)
  • Volume of intestinal fluid from subjects for analysis [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

Subjects must meet all of the following criteria to be included in the study:

  • Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
  • ASA Classifications 1 and 2.
  • For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
  • Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. Non-English speakers will not be included in the study because consent forms are in English, and any instructions during exercise will need to be provided in English.

Критерии исключения

Subjects with any of the following conditions or characteristics must be excluded from the study:

  • History of any of the following:
  • Prior gastric or esophageal surgery, including lap banding or bariatric surgery
  • Bowel obstruction
  • Gastric outlet obstruction
  • Diverticulitis
  • Inflammatory bowel disease
  • Ileostomy or colostomy
  • Gastric or esophageal cancer
  • Achalasia
  • Esophageal diverticulum
  • Active Dysphagia or Odynophagia
  • Active medication use for any gastrointestinal conditions
  • Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
  • Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
  • A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Stanford University — Stanford

Публикации

  • Shalon D, Culver RN, Grembi JA, Folz J, Treit PV, Shi H, Rosenberger FA, Dethlefsen L, Meng X, Yaffe E, Aranda-Diaz A, Geyer PE, Mueller-Reif JB, Spencer S, Patterson AD, Triadafilopoulos G, Holmes SP, Mann M, Fiehn O, Relman DA, Huang KC. Profiling the human intestinal environment under physiological conditions. Nature. 2023 May;617(7961):581-591. doi: 10.1038/s41586-023-05989-7. Epub 2023 May 10 PMID 37165188

Идентификаторы

NCT: NCT06903806 · IRB-67010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗