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Идёт набор NCT06211062

The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Фаза II С лечением ME/CFS IBS - Irritable Bowel Syndrome

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: Floradapt Intensive GI, Placebo.
Кому может быть актуально
Состояния в реестре: ME/CFS, IBS - Irritable Bowel Syndrome. Базовые параметры: 45 лет — 70 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
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Обзор

This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are: * how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface? * how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).

Подробное описание

This single-site comparison study will be performed on 100 participants, 45 to 70 years of age, who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with the irritable bowel syndrome (IBS), according to the Rome IV criteria. In this study, we will evaluate using the i3.1 probiotic compared to placebo. This is a randomized, placebo-controlled trial with four study arms that will include 25 participants per arm: Individuals with ME/CFS with and without IBS, who will take either the active medication i3.1 or placebo.

Вмешательства

  • Препарат Floradapt Intensive GI
    one capsule daily for the eight week intervention
  • Другое Placebo
    one capsule daily for the eight week intervention

Первичные конечные точки

  • The Incidence of Intervention-Related Adverse Events [Safety] [Срок оценки: from baseline to the eight week visit]
  • The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy] [Срок оценки: from baseline to the eight week visit]
  • level of CRP (C-reactive protein) [Срок оценки: from baseline to the eight week visit]
  • The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α [Срок оценки: from baseline to the eight week visit]
  • The Symptom Severity Measurement [Efficacy] [Срок оценки: from baseline to the eight week visit]
Вторичные конечные точки (2)
  • The Impact on the Irritable Bowel Syndrome (IBS) Severity [Срок оценки: from baseline to the eight week]
  • The IBS-related Quality of Life Measurement [Срок оценки: from the eight week visit to the 12 week visit]

Критерии участия

Inclusion Criteria: eligible if all of the following apply:

  • Meets IOM ME/CFS case definition criteria,
  • Co-morbid IBS: meets RomeIV criteria for alternating or diarrhea-predominant IBS as reported during screening (technically diagnosed by a physician),
  • Able to provide consent to study,
  • Patients of childbearing potential must practice effective contraception during the study and be willing to continue contraception for at least six months after the intervention,
  • agrees to participate in online surveys and follow-up visits.

Exclusion Criteria: ineligible if any of the following apply:

  • Probiotics in the past eight weeks,
  • Antibiotics in the past eight weeks,
  • Pregnancy or lactating women,
  • Medical conditions including short bowel syndrome, celiac disease, biliary disease, pancreatitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe cardiovascular, neurological condition, or liver failure,
  • Gastrointestinal surgery within six months of study entry,
  • History of psychiatric disorder, alcohol or illicit drug abuse.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Institute for Neuroimmune Medicine — Fort Lauderdale

Идентификаторы

NCT: NCT06211062 · 2020-631

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗