Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)Phase 2ORAL-LYO-FMTNCT06948461

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.

A Phase 2 study testing ORAL-LYO-FMT in people with Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D) and Recurrent Clostridioides Difficile Infection (rCDI), run by PharmaPlanter Technologies Inc.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 19 to 120 years
Conditions the study is for: Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D), Recurrent Clostridioides Difficile Infection (rCDI), Fecal Microbiota Therapy (FMT)
What is being tested?: ORAL-LYO-FMT
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: No sites listed yet
Study dates: 1 Sep 2025to Dec 2026
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

19 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;

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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.
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.

Who cannot join

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

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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
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About this study

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

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
Being tested: ORAL-LYO-FMT, Placebo
Keywords: IBS, Irritable bowel syndrome, rCDI, Fecal Microbiota Therapy, FMT, Gut Health, CDI, Clostridioides difficile infection, Recurrent
Medical subject headings: Irritable Bowel Syndrome, Clostridium Infections, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ORAL-LYO-FMTBiological
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.
PlaceboOther
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.

Study groups in NCT06948461
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: ORAL-LYO-FMT

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 8 weeks after completion of IP

Secondary outcomes (6)

CDI Recurrence Prevention at 24 Weeks
Proportion of participants with CDI who remain recurrence-free 24 weeks after IP completion.
Measured: 24 weeks post-treatment
Longitudinal IBS-SSS Improvement
Proportion of IBS-D participants with sustained improvement in IBS-SSS at 1, 3, and 6 months after IP completion.
Measured: 1, 3, and 6 months post-treatment
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.
Measured: Baseline, Week 4, Week 12, and Week 24
Hospital Anxiety and Depression Scale (HADS)
Change in HADS scores from baseline to 4, 12, and 24 weeks post-IP.
Measured: Baseline, Week 4, Week 12, and Week 24
Chronic Condition Changes
Proportion of participants with onset of new or improvement in existing chronic conditions, as reported in long-term follow-up questionnaire.
Measured: 24 weeks after completion of IP
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and severity of AEs or SAEs possibly or definitely related to IP, assessed via Naranjo Causality Assessment Scale.
Measured: Up to 8 weeks after completion of IP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2025Dec 2026

First posted29 Apr 2025
Study start1 Sep 2025 (estimated)
Primary completionSep 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Participant
Enrolment: 63 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06948461
Sponsor's protocol ID: Basket ORAL-LYO-FMT Trial
Acronym: ORAL-LYO-FMT
Status last verified: Apr 2025
First submitted: 21 Apr 2025
Last updated: 29 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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