Clinical trial NCT06948461: 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: PharmaPlanter Technologies Inc
Sponsor class: NETWORK
First posted: 2025-04-29
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


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

Exclusion Criteria:

-

Primary outcomes:
measure: Prevention of Recurrent CDI
timeFrame: 8 weeks after completion of IP
measure: Improvement in IBS Symptom Severity (IBS-SSS)
timeFrame: 8 weeks after completion of IP
Secondary outcomes:
measure: CDI Recurrence Prevention at 24 Weeks
timeFrame: 24 weeks post-treatment
measure: Longitudinal IBS-SSS Improvement
timeFrame: 1, 3, and 6 months post-treatment
measure: Quality of Life (VR-12 Score Change)
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Chronic Condition Changes
timeFrame: 24 weeks after completion of IP
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 8 weeks after completion of IP
Other outcomes:
Locations:
Study officials:
References: