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.

NCT ID: NCT06948461

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D); Recurrent Clostridioides Difficile Infection (rCDI); Fecal Microbiota Therapy (FMT); Irritable Bowel Syndrome (IBS); Clostridioides Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ORAL-LYO-FMT

Intervention Type: BIOLOGICAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

ORAL-LYO-FMT

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

ORAL-LYO-FMT

Intervention Type: BIOLOGICAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

ORAL-LYO-FMT

Intervention Type: BIOLOGICAL

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.

≥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.

Group Type: EXPERIMENTAL

ORAL-LYO-FMT

Intervention Type: BIOLOGICAL

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.

≥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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

≥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.

Group Type: EXPERIMENTAL

ORAL-LYO-FMT

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

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• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaPlanter Technologies Inc

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Basket ORAL-LYO-FMT Trial

Identifier Type: -

Identifier Source: org_study_id