A Flexible Clinical Trial to Test if Freeze-dried Fecal Microbiota Therapy Helps Treat Diarrhea-predominant Irritable Bowel Syndrome or Prevent Recurring C. Difficile Infections.

Официальное название

An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection

Обзор

The goal of this clinical trial is to learn if oral lyophilized fecal microbiota therapy (ORAL-LYO-FMT) helps treat diarrhea-predominant irritable bowel syndrome (IBS-D) and prevent the recurrence of Clostridioides difficile infection (rCDI). The main questions it aims to answer are: * Does ORAL-LYO-FMT reduce IBS symptoms? * Does it prevent rCDI after treatment? * What side effects or safety concerns might occur? Researchers will compare ORAL-LYO-FMT to a placebo (a look-alike capsule with no active treatment) to see how well it works. Participants will: * Be randomly assigned to take ORAL-LYO-FMT or placebo for up to 7 weeks * Take capsules three times per week (Monday, Wednesday, Friday) * Complete health questionnaires and have follow-up visits by phone or in person for up to 6 months The trial also looks at changes in quality of life, mood, and new or ongoing medical conditions over time.

Вмешательства

• Биопрепарат ORAL-LYO-FMT
  An oral capsule formulation of lyophilized fecal microbiota. Participants receive 7 capsules, three times per week (Monday, Wednesday, Friday), for either 4 or 7 weeks depending on treatment allocation. The product aims to restore healthy gut microbiota for treatment of IBS-D or prevention of rCDI.
• Другое Placebo
  Double-coated oral capsules visually identical to ORAL-LYO-FMT but containing no active material. Participants receive 7 capsules, three times per week, for either 3 or 7 weeks depending on treatment allocation.

Первичные конечные точки

• Prevention of Recurrent CDI [Срок оценки: 8 weeks after completion of IP]
• Improvement in IBS Symptom Severity (IBS-SSS) [Срок оценки: 8 weeks after completion of IP]

Вторичные конечные точки (6)

• CDI Recurrence Prevention at 24 Weeks [Срок оценки: 24 weeks post-treatment]
• Longitudinal IBS-SSS Improvement [Срок оценки: 1, 3, and 6 months post-treatment]
• Quality of Life (VR-12 Score Change) [Срок оценки: Baseline, Week 4, Week 12, and Week 24]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, Week 4, Week 12, and Week 24]
• Chronic Condition Changes [Срок оценки: 24 weeks after completion of IP]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 8 weeks after completion of IP]

Критерии участия

Критерии включения

• 19 years of age and older
• Able to provide informed consent
• Must have at least one of the 3 following conditions:

• Irritable bowel syndrome with diarrhea- predominant (IBS-D) as reported by patients of type 6 or 7 in Bristol stool chart and Rome IV diagnostic criteria:

• Recurrent abdominal pain/discomfort\*\* at least 3 days/month in last 3 months associated with ≥2 of the following:
• Symptom improvement with defecation;
• Onset associated with change in stool frequency;
• Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset > 6 months prior to diagnosis
• Primary or 1 episode recurrent Clostridioides difficile infection which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.
• 2 or more episodes of recurrent Clostridioides difficile infection, which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.

Критерии исключения

• Planned or actively taking other investigational product
• Unable to tolerate FMT or take oral medications.
• Requiring systemic antibiotic therapy at the time of FMT
• Actively taking probiotics \[Consumption of yogurt is permitted\]
• Severe allergy to any food and/or medications
• Major open abdominal surgery within the past 60 days
• Receipt of chemotherapy or radiation within 8 weeks of screening.
• Active small bowel obstruction.
• Those who are pregnant or plan to be pregnant within 3 months of the study. This will be determined on history alone at time of study entry and subsequent follow up.
• Those who are breastfeeding or plan to breast feed during the trial
• Not expected to survive beyond 30 days.
• Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the study team

Критерии исключения

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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

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06948461 · Basket ORAL-LYO-FMT Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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