Trial intelligence / Profile preview

ORAL-LYO-FMT for IBS-D and Recurrent C. difficile Infection

NCT06948461Phase 2

Key facts

Status: Not yet recruiting
Start: Sep 2025
Primary completion: Sep 2026
Sponsor: PharmaPlanter Technologies
Modality: Live Biotherapeutic Products

Drugs: ORAL-LYO-FMT
Conditions: Irritable bowel syndrome with diarrhea (IBS-D)Clostridioides difficile infection (CDI)

Overview

Phase 2, randomised, double-blind trial of ORAL-LYO-FMT in Irritable bowel syndrome with diarrhea (IBS-D) and Clostridioides difficile infection (CDI) (9 arms), sponsored by PharmaPlanter Technologies. Primary endpoints: Prevention of Recurrent CDI and Improvement in IBS Symptom Severity. Planned start Sep 2025; status: not yet recruiting.

Design

9 arms

Study design: RandomizedDouble-blind

IBS-D - ORAL-LYO-FMT 7 Weeks
IBS-D patients receiving ORAL-LYO-FMT for 7 weeks
IBS-D - Placebo 7 Weeks
IBS-D patients receiving Placebo for 7 weeks
IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks
IBS-D patients receiving ORAL-LYO-FMT for 4 weeks then Placebo for 3 weeks
Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks
Primary/1st rCDI patients receiving ORAL-LYO-FMT for 7 weeks
Primary/1st rCDI - Placebo 7 Weeks
Primary/1st rCDI patients receiving Placebo for 7 weeks
Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks
Primary/1st rCDI patients receiving ORAL-LYO-FMT for 4 weeks then Placebo for 3 weeks

3 more in the full profile.

Who it enrols

Adults aged 19+ with either IBS-D (Rome IV) or Primary/Recurrent CDI responding to antibiotic treatment. Excludes those requiring systemic antibiotics at time of FMT, pregnant/breastfeeding, or with severe allergies/recent abdominal surgery.

Endpoints

Primary

Prevention of Recurrent CDI8 weeks post-treatment
Improvement in IBS Symptom Severity8 weeks post-treatment

Secondary

CDI Recurrence Prevention at 24 Weeks24 weeks post-treatment
Longitudinal IBS-SSS Improvement6 months post-treatment
Quality of Life (VR-12 Score Change)Week 24
Hospital Anxiety and Depression ScaleWeek 24
Chronic Condition Changes24 weeks post-treatment
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to 8 weeks post-treatment

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