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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
63
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.
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.
Prevention of Recurrent CDI
Proportion of participants with Clostridioides difficile infection (CDI) who do not experience recurrence within 8 weeks following completion of the investigational product (IP).
Time frame: 8 weeks after completion of IP
Improvement in IBS Symptom Severity (IBS-SSS)
Proportion of IBS-D participants with a reduction in IBS Symptom Severity Score (IBS-SSS) of more than 150 points compared to baseline.
Time frame: 8 weeks after completion of IP
CDI Recurrence Prevention at 24 Weeks
Proportion of participants with CDI who remain recurrence-free 24 weeks after IP completion.
Time frame: 24 weeks post-treatment
Longitudinal IBS-SSS Improvement
Proportion of IBS-D participants with sustained improvement in IBS-SSS at 1, 3, and 6 months after IP completion.
Time frame: 1, 3, and 6 months post-treatment
Quality of Life (VR-12 Score Change)
Change in Veterans RAND 12 Item Health Survey (VR-12) scores at baseline, 4 weeks from IP initiation, and 12 and 24 weeks post-IP.
Time frame: Baseline, Week 4, Week 12, and Week 24
Hospital Anxiety and Depression Scale (HADS)
Change in HADS scores from baseline to 4, 12, and 24 weeks post-IP.
Time frame: Baseline, Week 4, Week 12, and Week 24
Chronic Condition Changes
Proportion of participants with onset of new or improvement in existing chronic conditions, as reported in long-term follow-up questionnaire.
Time frame: 24 weeks after completion of IP
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and severity of AEs or SAEs possibly or definitely related to IP, assessed via Naranjo Causality Assessment Scale.
Time frame: Up to 8 weeks after completion of IP
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