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.
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
- Are there results?
- Not yet: the study is under way
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
- -
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
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- PharmaPlanter Technologies Inc
- Sponsor type
- Research network
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06948461
- Acronym / sponsor ID
- ORAL-LYO-FMT / Basket ORAL-LYO-FMT Trial
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- PharmaPlanter Technologies IncResearch network
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 9
- 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.
| Arm | Type | Receives |
|---|---|---|
| IBS-D - ORAL-LYO-FMT 7 Weeks | Experimental | Biological: ORAL-LYO-FMTParticipants 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. |
| IBS-D - Placebo 7 Weeks | Placebo comparator | Other: PlaceboParticipants with IBS-D receive 7 oral placebo capsules (double-coated and visually identical to active capsules) three times per week for 7 weeks. |
| IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks | Experimental | Biological: ORAL-LYO-FMTParticipants 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. |
| Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks | Experimental | Biological: ORAL-LYO-FMTParticipants 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. |
| Primary/1st rCDI - Placebo 7 Weeks | Placebo comparator | Other: PlaceboParticipants with primary or first episode rCDI receive 7 oral placebo capsules three times per week for 7 weeks. |
| Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks | Experimental | Biological: ORAL-LYO-FMTParticipants 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. |
| ≥2 rCDI - ORAL-LYO-FMT 7 Weeks | Experimental | Biological: ORAL-LYO-FMTParticipants with two or more episodes of rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 7 weeks. |
| ≥2 rCDI - Placebo 7 Weeks | Placebo comparator | Other: PlaceboParticipants with two or more episodes of rCDI receive 7 oral placebo capsules three times per week for 7 weeks. |
| ≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks | Experimental | Biological: ORAL-LYO-FMTParticipants 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. |
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 19 years of age and older
- Able to provide informed consent
- Must have at least one of the 3 following conditions:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORAL-LYO-FMTAn 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. | Biological | 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 |
| PlaceboDouble-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. | Other | IBS-D - Placebo 7 Weeks, Primary/1st rCDI - Placebo 7 Weeks, ≥2 rCDI - Placebo 7 Weeks |
Primary outcome
Prevention of Recurrent CDI
Time frame: 8 weeks after completion of IP
Proportion of participants with Clostridioides difficile infection (CDI) who do not experience recurrence within 8 weeks following completion of the investigational product (IP).
Improvement in IBS Symptom Severity (IBS-SSS)
Time frame: 8 weeks after completion of IP
Proportion of IBS-D participants with a reduction in IBS Symptom Severity Score (IBS-SSS) of more than 150 points compared to baseline.
6 secondary outcomes
CDI Recurrence Prevention at 24 Weeks
Time frame: 24 weeks post-treatment
Longitudinal IBS-SSS Improvement
Time frame: 1, 3, and 6 months post-treatment
Quality of Life (VR-12 Score Change)
Time frame: Baseline, Week 4, Week 12, and Week 24
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Week 4, Week 12, and Week 24
Chronic Condition Changes
Time frame: 24 weeks after completion of IP
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 8 weeks after completion of IP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Recurrent CDI (time frame: 8 weeks after completion of IP). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.