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. (ORAL-LYO-FMT)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome (IBS); Clostridioides Difficile Infection; Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D); Recurrent Clostridioides Difficile Infection (rCDI); Fecal Microbiota Therapy (FMT)
• Intervention / Treatment: Biological: ORAL-LYO-FMT; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 19 years of age and older
• Able to provide informed consent

• Must have at least one of the 3 following conditions:

  1. 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:

     1. Recurrent abdominal pain/discomfort** at least 3 days/month in last 3 months associated with ≥2 of the following:
     2. Symptom improvement with defecation;
     3. Onset associated with change in stool frequency;
     4. Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset > 6 months prior to diagnosis
  2. 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.
  3. 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.

Exclusion Criteria:

1. Planned or actively taking other investigational product
2. Unable to tolerate FMT or take oral medications.
3. Requiring systemic antibiotic therapy at the time of FMT
4. Actively taking probiotics [Consumption of yogurt is permitted]
5. Severe allergy to any food and/or medications
6. Major open abdominal surgery within the past 60 days
7. Receipt of chemotherapy or radiation within 8 weeks of screening.
8. Active small bowel obstruction.
9. 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.
10. Those who are breastfeeding or plan to breast feed during the trial
11. Not expected to survive beyond 30 days.
12. 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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.
Placebo Comparator: 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.	Other: 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.
Experimental: 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.	Biological: 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.
Experimental: 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.	Biological: 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.
Placebo Comparator: 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.	Other: 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.
Experimental: 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.	Biological: 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.
Experimental: ≥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.	Biological: 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.
Placebo Comparator: ≥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.	Other: 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.
Experimental: ≥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.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	8 weeks after completion of IP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDI Recurrence Prevention at 24 Weeks	Proportion of participants with CDI who remain recurrence-free 24 weeks after IP completion.	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.	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.	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.	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.	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.	Up to 8 weeks after completion of IP

Collaborators and Investigators

• Sponsor: PharmaPlanter Technologies Inc

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: IBS; FMT; CDI; Irritable bowel syndrome; rCDI; Gut Health; Fecal Microbiota Therapy; Clostridioides difficile infection, Recurrent
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Irritable Bowel Syndrome; Syndrome; Recurrence; Infections; Communicable Diseases; Clostridium Infections; Diarrhea
• Other Study ID Numbers: Basket ORAL-LYO-FMT Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No