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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.

ConditionsIrritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)Recurrent Clostridioides Difficile Infection (rCDI)Fecal Microbiota Therapy (FMT)Irritable Bowel Syndrome (IBS)Clostridioides Difficile Infection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-120
SponsorPharmaPlanter Technologies Inc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

19 years of age and older

Able to provide informed consent

Symptom improvement with defecation;

Onset associated with change in stool frequency;

Disqualifiers

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]

Trial design

Design model

Parallel

Treatments tested in this trial

  • ORAL-LYO-FMT

    Biological/Vaccine

    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

    Other intervention

    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.

Treatment groups

63 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: IBS-D - ORAL-LYO-FMT 7 WeeksExperimental treatment 1 intervention
Group B: IBS-D - Placebo 7 WeeksPlacebo comparator 1 intervention
Group C: IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 WeeksExperimental treatment 1 intervention
Group D: Primary/1st rCDI - ORAL-LYO-FMT 7 WeeksExperimental treatment 1 intervention
Group E: Primary/1st rCDI - Placebo 7 WeeksPlacebo comparator 1 intervention
Group F: Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 WeeksExperimental treatment 1 intervention
Group G: ≥2 rCDI - ORAL-LYO-FMT 7 WeeksExperimental treatment 1 intervention
Group H: ≥2 rCDI - Placebo 7 WeeksPlacebo comparator 1 intervention
Group I: ≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 WeeksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
8 weeks after completion of IP
2

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.

Time frame
8 weeks after completion of IP

Secondary outcomes

1

CDI Recurrence Prevention at 24 Weeks

Proportion of participants with CDI who remain recurrence-free 24 weeks after IP completion.

Time frame
24 weeks post-treatment
2

Longitudinal IBS-SSS Improvement

Proportion of IBS-D participants with sustained improvement in IBS-SSS at 1, 3, and 6 months after IP completion.

Time frame
1, 3, and 6 months post-treatment
3

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.

Time frame
Baseline, Week 4, Week 12, and Week 24
4

Hospital Anxiety and Depression Scale (HADS)

Change in HADS scores from baseline to 4, 12, and 24 weeks post-IP.

Time frame
Baseline, Week 4, Week 12, and Week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PharmaPlanter Technologies Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: