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Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Ранняя фаза I С лечением Hidradenitis Suppurativa

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: Fecal Microbiota - lyophilized, Placebo drug.
Кому может быть актуально
Состояния в реестре: Hidradenitis Suppurativa. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

HS is relatively common in the United States with a prevalence of 0.1-1.0%. 1 HS has a dramatic impact on quality of life, significantly more so than other chronic skin diseases, such as psoriasis or atopic dermatitis (AD). HS also has a large economic impact, due to frequent emergency department and inpatient care utilization, and re-hospitalization rates similar to congestive heart failure. Unfortunately, few treatment options are effective. There are currently three FDA-approved treatments for HS, including adalimumab, secukinumab, and bimekizumab, each with only 40- 60% respond to treatment and over 50% lose response within one year . The overarching goal of this pilot study is to investigate the central hypothesis that oral microbiota transplant therapy(MTT) alters the gut microbiome in patients with Hidradenitis Suppurativa (HS), influencing cutaneous microbiota via systemically absorbed gut-derived metabolites.

Вмешательства

  • Препарат Fecal Microbiota - lyophilized
    Patients receive 2 capsules daily for one week followed by one capsule daily for 2 weeks. MTT capsules are derived from a single donor per patient.
  • Препарат Placebo drug
    The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product.

Первичные конечные точки

  • Percent donor engraftment [Срок оценки: Baseline, 6 weeks, 12 weeks]
Вторичные конечные точки (12)
  • Skin toxonomic relative abundances and diversity indices [Срок оценки: 6 weeks, 12 weeks]
  • Stool toxonomic relative abundances and diversity indices [Срок оценки: 6 weeks, 12 weeks]
  • Stool small chain fatty acids [Срок оценки: 12 weeks]
  • Serum small chain fatty acids [Срок оценки: 12 weeks]
  • Stool small molecule metabolites [Срок оценки: 6 weeks, 12 weeks]
  • Physician-reported clinical response 1 [Срок оценки: 12 weeks]
  • Physician-reported clinical response 2 [Срок оценки: 12 weeks]
  • Change in IHS4 [Срок оценки: 12 weeks]
  • Change in total draining tunnel count [Срок оценки: 12 weeks]
  • Change in the Hidradenitis Suppurativa Activity and Severity Index [Срок оценки: 12 weeks]
  • Change in Hidradenitis Suppurativa quality of life (HiSQOL) [Срок оценки: 12 weeks]
  • Change in Dermatology Life Quality Index (DLQI) [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Able and willing to provide informed consent
  • English speaking
  • Age >= 18years of age
  • Diagnosis of hidradenitis suppurativa by a dermatologist
  • Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g. absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g. oral contraception, transdermal patch, barrier, intrauterine device). Periodic abstinence and early withdraw are not acceptable methods
  • Able to comply to study measures in the opinion of the investigator.
  • Stable doses of all medications for 30 days prior to baseline

Критерии исключения

  • Non-English speaking
  • Refusal or inability to provide informed consent
  • Planning on moving within 6 months from start of study
  • Allergy to neomycin or vancomycin
  • Anaphylactic food allergies
  • Pregnancy, breastfeeding or planning pregnancy during study period (negative pregnancy test needed for persons of childbearing potential)
  • Use of any topical or oral antibiotics within 30 days of randomization
  • Use of any oral antibiotics within 90 days of randomization
  • History of inflammatory bowel disease
  • Extensive bowel resection (e.g., subtotal colectomy, substantial removal of small bowel)
  • No major bowel surgery within 4 weeks prior to baseline or planned major surgery during the study period
  • No active skin disease other than HS that could interfere with assessments

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
  • University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06058520 · DERM-2023-31562

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗