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Идёт набор NCT06285734

Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention

— Наблюдательное Abdominal Distention

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: Breath test.
Кому может быть актуально
Состояния в реестре: Abdominal Distention. Базовые параметры: 18 лет — 60 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
Китай
Следующий шаг
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Обзор

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

Подробное описание

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of abdominal distension is high in the population. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between the clinical features such as severity, location, and frequency of abdominal distension and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

Вмешательства

  • Диагностический тест Breath test
    The concentration of methane and hydrogen in the exhaled gas of patients with Abdominal distention is measured by a breath test to determine the presence of SIBO and abnormal OCTT.

Первичные конечные точки

  • Positive rate of SIBO in patients with abdominal distension [Срок оценки: 2024-03-01 to 2025-08-01]
Вторичные конечные точки (3)
  • Positive rate of abnormal OCTT in patients with abdominal distension [Срок оценки: 2024-03-01 to 2025-08-01]
  • Correlation between clinical features of patients with abdominal distension and SIBO [Срок оценки: 2024-03-01 to 2025-08-01]
  • Correlation between clinical features of patients with abdominal distension and OCTT [Срок оценки: 2024-03-01 to 2025-08-01]

Критерии участия

Критерии включения

  • Patients aged 18 to 70 years.
  • Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.

Критерии исключения

  • Patients who are pregnant or lactating.
  • Patients have history of gastrointestinal malignancy or gastrointestinal surgery.
  • Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.
  • Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.
  • Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.
  • Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.
  • Patients who are unwilling or incapable to provide informed consents.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Gastroenterology Department of Qilu Hospital — Цзинань

Идентификаторы

NCT: NCT06285734 · KYLL-202312-049

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗