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Идёт набор NCT05587036

Effects of Rifaximin on Gut Microbiota and Emotion

Фаза II / Фаза III С лечением Healthy Volunteers Stress Fear

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: Rifaximin, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers, Stress, Fear. Базовые параметры: 18 лет — 50 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Triple-blind, Placebo-controlled Study on the Effect of Rifaximin on Psychobiological Functions in Healthy Men

Обзор

A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.

Подробное описание

This study is a randomized, triple-blind, placebo-controlled, interventional trial aiming to elucidate the impact of rifaximin-induced gut microbiota alteration to the psychobiological functioning of healthy men. The intervention will be performed in a parallel group design where one group will receive rifaximin (Targaxan 550 mg) twice daily for two weeks (treatment arm), while the other group will receive placebo (placebo arm).

Primary objective: to test the effect of rifaximin on stress sensitivity and fear-related processes

Secondary objective: to determine the mediating and/or moderating factors that underlie rifaximin-induced psychobiological changes

Вмешательства

  • Препарат Rifaximin
    Rifaximin oral tablet, 550 mg, twice daily, two-weeks
  • Пищевая добавка Placebo
    Placebo oral tablet, twice daily, two-weeks

Первичные конечные точки

  • Stress sensitivity (biological) [Срок оценки: Throughout study completion, on average 1 year]
  • Stress sensitivity (psychological) [Срок оценки: Throughout study completion, on average 1 year]
  • Fear (biological) [Срок оценки: Throughout study completion, on average 1 year]
  • Fear (psychological) [Срок оценки: Throughout study completion, on average 1 year]
Вторичные конечные точки (6)
  • Positive and Negative Affect Schedule (PANAS) [Срок оценки: Throughout study completion, on average 1 year]
  • Perceived Stress Scale (PSS) [Срок оценки: Throughout study completion, on average 1 year]
  • Gastrointestinal Symptom Rating Scale (GSRS) [Срок оценки: Throughout study completion, on average 1 year]
  • Leiden Index of Depression Sensitivity (LEIDS-R) [Срок оценки: Throughout study completion, on average 1 year]
  • State-Trait Anxiety Inventory, State Anxiety Subscale (STAI-S) [Срок оценки: Throughout study completion, on average 1 year]
  • Brain response to stress [Срок оценки: Throughout study completion, on average 1 year]

Критерии участия

Критерии включения

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • Proficiency in English and/or Dutch
  • Healthy with no intestinal and/or psychological complaints
  • Access to a -18°C freezer (i.e. ordinary household freezer)
  • Male participants
  • Age 18-50 years
  • BMI 18.5-25 kg/m2

Критерии исключения

  • Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder
  • Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol
  • Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial
  • Participation in an interventional Trial with an investigational medicinal product (IMP) or device
  • Hypersensitivity to the active substance rifaximin, to any rifamycin (e.g. rifampicin or rifabutin) or any of the excipients
  • Current or recent medication use
  • Use of antibiotics within three months preceding the study
  • Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.)
  • Previous or current substance/alcohol dependence or abuse (>2 units per day or 14 units per week)
  • One or more diagnoses based on the mini international neuropsychiatric interview (MINI-S)
  • One or more diagnoses based on ROME IV for gastrointestinal disorders
  • Smoking
  • Night-shift work
  • Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.)
  • Use of pre- or probiotics within one month preceding the study
  • Previous experience with any of the tasks used in the study (not including questionnaires)
  • Color vision deficiency (colorblindness)
  • Magnetic Resonance Imaging (MRI) contraindications, including claustrophobia, severe back problems, conditions that would interfere with MRI scanning (e.g. cochlear implant, metal fragments in eyes, metallic body inclusion, or other metal implanted in the body), and if the participant does not want to be informed of incidental findings that might be found during imaging.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Бельгия · 1 центр
  • UZ/KU Leuven — Leuven

Идентификаторы

NCT: NCT05587036 · S66407 · 2021-006814-35

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗