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.

NCT06948461 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Basket ORAL-LYO-FMT Trial
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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

Keywords

IBS; Irritable bowel syndrome; rCDI; Fecal Microbiota Therapy; FMT; Gut Health; CDI; Clostridioides difficile infection, Recurrent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• CDI Recurrence Prevention at 24 Weeks

  24 weeks post-treatment

• Longitudinal IBS-SSS Improvement

  1, 3, and 6 months post-treatment

• Quality of Life (VR-12 Score Change)

  Baseline, Week 4, Week 12, and Week 24

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, Week 4, Week 12, and Week 24

• Chronic Condition Changes

  24 weeks after completion of IP

Study Arms (9)

IBS-D - ORAL-LYO-FMT 7 Weeks

EXPERIMENTAL

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

IBS-D - Placebo 7 Weeks

PLACEBO COMPARATOR

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Primary/1st rCDI - Placebo 7 Weeks

PLACEBO COMPARATOR

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

Other: Placebo

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

EXPERIMENTAL

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

≥2 rCDI - ORAL-LYO-FMT 7 Weeks

EXPERIMENTAL

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

≥2 rCDI - Placebo 7 Weeks

PLACEBO COMPARATOR

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

Other: Placebo

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

EXPERIMENTAL

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

Interventions

ORAL-LYO-FMT 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 - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks; IBS-D - ORAL-LYO-FMT 7 Weeks; Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks; Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks; ≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks; ≥2 rCDI - ORAL-LYO-FMT 7 Weeks

Placebo 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 - Placebo 7 Weeks; Primary/1st rCDI - Placebo 7 Weeks; ≥2 rCDI - Placebo 7 Weeks

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Able to provide informed consent
• Must have at least one of the 3 following conditions:
• 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:
• Recurrent abdominal pain/discomfort\*\* at least 3 days/month in last 3 months associated with ≥2 of the following:
• Symptom improvement with defecation;
• Onset associated with change in stool frequency;
• Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset \> 6 months prior to diagnosis
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• PharmaPlanter Technologies Inc: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome; Clostridium Infections; Recurrence

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This trial will use both a basket trial design and a parallel Simon two-stage design to reduce the time and costs to determine whether ORAL-LYO-FMT is effective and safe for IBS-D, and in prevention of additional recurrence of CDI for primary or rCDI. Basket trials are an innovative trial design that has been developed as an efficient way to determine safety and efficacy of experimental therapeutics across multiple patient populations and diseases. Basket trials assess the effectiveness of a drug based on its mechanism of action rather than the underlying disease. This type of trial design is widely used in oncology research and is now expanding to other disease states. In addition, a basket design offers benefits over traditional trials, including enabling studies to be conducted over a shorter time period, allowing smaller sample size, and thus, reducing costs. In this trial, a parallel Simon two-stage design will be carried out for each basket.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04