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)

PharmaPlanter Technologies Inc

Status and phase: Begins enrollment in 1 month; Phase 2

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

Treatments: Other: Placebo; Biological: ORAL-LYO-FMT

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06948461

Basket ORAL-LYO-FMT Trial

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 19 to 120 years old

Volunteers: No Healthy Volunteers

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:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 9 patient groups, including a placebo group

IBS-D - ORAL-LYO-FMT 7 Weeks

Experimental group

Description:

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.

Treatment:

Biological: ORAL-LYO-FMT

IBS-D - Placebo 7 Weeks

Placebo Comparator group

Description:

Participants with IBS-D receive 7 oral placebo capsules (double-coated and visually identical to active capsules) three times per week for 7 weeks.

Treatment:

Other: Placebo

IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks

Experimental group

Description:

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.

Treatment:

Biological: ORAL-LYO-FMT

Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks

Experimental group

Description:

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.

Treatment:

Biological: ORAL-LYO-FMT

Primary/1st rCDI - Placebo 7 Weeks

Placebo Comparator group

Description:

Participants with primary or first episode rCDI receive 7 oral placebo capsules three times per week for 7 weeks.

Treatment:

Other: Placebo

Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks

Experimental group

Description:

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.

Treatment:

Biological: ORAL-LYO-FMT

≥2 rCDI - ORAL-LYO-FMT 7 Weeks

Experimental group

Description:

Participants with two or more episodes of rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 7 weeks.

Treatment:

Biological: ORAL-LYO-FMT

≥2 rCDI - Placebo 7 Weeks

Placebo Comparator group

Description:

Participants with two or more episodes of rCDI receive 7 oral placebo capsules three times per week for 7 weeks.

Treatment:

Other: Placebo

≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks

Experimental group

Description:

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.

Treatment:

Biological: ORAL-LYO-FMT