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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 主要终点
- Prevention of Recurrent CDI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Exclusion Criteria:
研究组 & 干预措施
IBS-D - ORAL-LYO-FMT 7 Weeks
Participants with diarrhea-predominant irritable bowel syndrome (IBS-D) receive 7 oral capsules of ORAL-LYO-FMT three times per week (Monday, Wednesday, Friday) for 7 weeks.
干预措施: ORAL-LYO-FMT (Biological)
IBS-D - Placebo 7 Weeks
Participants with IBS-D receive 7 oral placebo capsules (double-coated and visually identical to active capsules) three times per week for 7 weeks.
干预措施: Placebo (Other)
IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks
Participants with IBS-D receive 7 oral capsules of ORAL-LYO-FMT three times per week for 4 weeks, followed by 7 oral placebo capsules three times per week for 3 weeks.
干预措施: ORAL-LYO-FMT (Biological)
Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks
Participants with a primary or first episode of recurrent Clostridioides difficile infection (rCDI) receive 7 oral capsules of ORAL-LYO-FMT three times per week for 7 weeks.
干预措施: ORAL-LYO-FMT (Biological)
Primary/1st rCDI - Placebo 7 Weeks
Participants with primary or first episode rCDI receive 7 oral placebo capsules three times per week for 7 weeks.
干预措施: Placebo (Other)
Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks
Participants with primary or first episode rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 4 weeks, followed by placebo capsules three times per week for 3 weeks.
干预措施: ORAL-LYO-FMT (Biological)
≥2 rCDI - ORAL-LYO-FMT 7 Weeks
Participants with two or more episodes of rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 7 weeks.
干预措施: ORAL-LYO-FMT (Biological)
≥2 rCDI - Placebo 7 Weeks
Participants with two or more episodes of rCDI receive 7 oral placebo capsules three times per week for 7 weeks.
干预措施: Placebo (Other)
≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks
Participants with two or more episodes of rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 4 weeks, followed by 3 weeks of placebo capsules.
干预措施: ORAL-LYO-FMT (Biological)
结局指标
主要结局
Prevention of Recurrent CDI
时间窗: 8 weeks after completion of IP
Proportion of participants with Clostridioides difficile infection (CDI) who do not experience recurrence within 8 weeks following completion of the investigational product (IP).
Improvement in IBS Symptom Severity (IBS-SSS)
时间窗: 8 weeks after completion of IP
Proportion of IBS-D participants with a reduction in IBS Symptom Severity Score (IBS-SSS) of more than 150 points compared to baseline.
次要结局
- Longitudinal IBS-SSS Improvement(1, 3, and 6 months post-treatment)
- CDI Recurrence Prevention at 24 Weeks(24 weeks post-treatment)
- Quality of Life (VR-12 Score Change)(Baseline, Week 4, Week 12, and Week 24)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, Week 4, Week 12, and Week 24)
- Chronic Condition Changes(24 weeks after completion of IP)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 8 weeks after completion of IP)