Ulcerative ColitisPhase 2/3NCT07154784
Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
A Phase 2/3 study testing Fecal microbiota transplantation (FMT) in people with Ulcerative Colitis and Fecal Microbiota Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to perform fecal microbiota transplantation (FMT) and analyze its effects in selected patients aged between 10 and 80 years who have been diagnosed with ulcerative colitis and have been receiving treatment for more than three months at Seoul National University Hospital, Seoul National University… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Fecal Microbiota Transplantation
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2023to 30 Jun 2027
- Phase
- Phase 2/3
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 10 and 80 years
- History of ulcerative colitis for at least 3 months
- Mild to moderate ulcerative colitis with a Mayo score of 4-10 or a partial Mayo score of 2-7
- Endoscopic evidence of rectal involvement extending at least 5 cm
- Willingness to provide written informed consent for participation in this clinical trial
Who cannot join
- Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12)
- Neutropenia (absolute neutrophil count < 500)
- Pregnancy
- Infectious colitis not caused by Clostridioides difficile
- History of colectomy (excluding appendectomy)
- History of antibiotic use within the past 2 weeks
Show all 13Show fewer
- Use of corticosteroids > 20 mg within the past 4 weeks
- Current or planned use of biologics (e.g., anti-TNF-α antibodies, anti-α4β7 integrin monoclonal antibodies, JAK inhibitors, anti-IL-12/IL-23 antibodies)
- Major food allergy
- Indeterminate colitis
- Comorbid chronic diseases such as chronic liver disease, heart failure, or chronic obstructive pulmonary disease (COPD)
- Refusal to participate in the study
- Any other condition deemed inappropriate for study participation by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine
Seoul, Dongjak-gu, 07061
About this study
This study aims to perform fecal microbiota transplantation (FMT) and analyze its effects in selected patients aged between 10 and 80 years who have been diagnosed with ulcerative colitis and have been receiving treatment for more than three months at Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this analysis, the study seeks to identify the long-term efficacy of FMT as a treatment for ulcerative colitis, evaluate the safety of the procedure, and establish a foundation for personalized FMT based on gut microbiota analysis.
Read the detailed description
The pathogenesis of inflammatory bowel disease (IBD) is thought to result from a complex interplay of genetic predisposition, environmental factors such as diet and gut microbiota, and immunological mechanisms. Among these, increasing attention has been given to the role of the gut microbiota, which resides on the intestinal mucosal surface and plays a key role in regulating host immune responses. Emerging evidence suggests that alterations in gut microbiota, as well as viruses that influence microbial composition, are closely associated with IBD.
In 2013, a landmark study published in the New England Journal of Medicine demonstrated that fecal microbiota transplantation (FMT)-a procedure in which processed stool from a healthy donor is delivered into a patient's colon via colonoscopy-significantly reduced the recurrence of antibiotic-associated Clostridioides difficile infection. Since then, FMT has been actively studied, particularly for its therapeutic potential in ulcerative colitis, a subtype of IBD.
Randomized controlled trials have investigated various methods of FMT delivery in ulcerative colitis, including colonoscopy, sigmoidoscopy, and oral capsules. No significant differences in efficacy have been reported between endoscopic and oral routes. In a domestic study on multidrug-resistant organisms, oral capsules showed promising outcomes in restoring microbial balance when compared with endoscopy and nasogastric tube administration.
While FMT delivery methods in Western countries are evolving from inpatient colonoscopic administration to outpatient enema or capsule-based regimens, South Korea currently lacks clinical research infrastructure for FMT beyond case reports. Although a few cases of FMT in IBD patients have been documented, no center has conducted formal clinical trials.
Therefore, this study aims to evaluate the clinical efficacy and underlying mechanisms of FMT in Korean patients with IBD, especially those with ulcerative colitis. Through this investigation, we seek to clarify the long-term therapeutic potential and safety of fecal microbiota transplantation in this population.
- Being tested
- Fecal microbiota transplantation (FMT)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Biological
Fecal microbiota transplantation (FMT) will be performed at weeks 0 and 4 of study enrollment by administering approximately 250-300 cc of a multi-donor fecal suspension into the colon via sigmoidoscopy, colonoscopy, or by oral administration of an equivalent amount (4 capsules).
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis patient | Experimental | This was a multicenter, prospective study that enrolled patients diagnosed with ulcerative colitis who were aged between 10 and 80 years and had been receiving treatment for at least 3 months. Eligible participants were required to meet all of the following inclusion criteria:
1. age between 10 and 80 years;
2. a disease duration of ulcerative colitis of at least 3 months;
3. mild to moderate disease activity, defined by a Mayo score of 4-10 or a partial Mayo score of 2-7;
4. endoscopic evidence of rectal involvement extending ≥5 cm; and
5. willingness to provide written informed consent for participation in the study. Receives: Biological: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary outcome
- Steroid-free Clinical Response at Week 12 Mayo score ≥3 and ≥30% ↓ from baseline, with rectal bleeding subscore ↓ ≥1 or ≤1, without steroid use. Unit: Participants
- Steroid-free Clinical Remission at Week 12 Mayo score ≤2 and no subscore >1, without steroid use. Unit: Participants
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Secondary outcomes (10)
Co-secondary outcome
1.Clinical Response at Week 12 and 48 Mayo ≥3 and ≥30%↓, rectal bleeding subscore ↓≥1 or ≤1. Unit: Participants
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
2.Clinical Remission at Week 12 and 48 Mayo ≤2 and all subscores ≤1. Unit: Participants
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
3.Endoscopic Response at Week 12 and 48 Mayo endoscopic subscore ↓≥1 from baseline. Unit: Participants
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
4.Endoscopic Remission at Week 12 and 48 Mayo endoscopic subscore = 0. Unit: Participants
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
5.CRP Change at Week 12 and 48 Change in serum CRP from baseline. Unit: mg/dL
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
6.ESR Change at Week 12 and 48 Change in ESR from baseline. Unit: mm/hr
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
7.Fecal Calprotectin Change at Week 12 and 48 Change from baseline. Unit: mg/kg
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
8.Microbiome Change at Week 12 and 48 Change in % relative abundance via 16S rRNA or shotgun. Unit: % relative abundance
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
9.Cytokine Change at Week 12 and 48 Change in mucosal cytokine levels from baseline. Unit: pg/mL
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
10.Single-cell RNA Expression Change at Week 12 and 48 Change in gene expression from serum (scRNA-seq). Unit: Fold change
Measured: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start19 Jul 2023
- Primary completion19 Jul 2023
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Inha University Hospital, Seoul National University Boramae Hospital
- Responsible party
- Principal investigator, KwangWoo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154784
- Sponsor's protocol ID
- 2021-0314
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07154784
- Acronym / sponsor ID
- 2021-0314
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Inha University Hospital, Seoul National University Boramae Hospital
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Sep 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.
This study aims to perform fecal microbiota transplantation (FMT) and analyze its effects in selected patients aged between 10 and 80 years who have been diagnosed with ulcerative colitis and have been receiving treatment for more than three months at Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this analysis, the study seeks to identify the long-term efficacy of FMT as a treatment for ulcerative colitis, evaluate the safety of the procedure, and establish a foundation for personalized FMT based on gut microbiota analysis.
Detailed description
The pathogenesis of inflammatory bowel disease (IBD) is thought to result from a complex interplay of genetic predisposition, environmental factors such as diet and gut microbiota, and immunological mechanisms. Among these, increasing attention has been given to the role of the gut microbiota, which resides on the intestinal mucosal surface and plays a key role in regulating host immune responses. Emerging evidence suggests that alterations in gut microbiota, as well as viruses that influence microbial composition, are closely associated with IBD.
In 2013, a landmark study published in the New England Journal of Medicine demonstrated that fecal microbiota transplantation (FMT)-a procedure in which processed stool from a healthy donor is delivered into a patient's colon via colonoscopy-significantly reduced the recurrence of antibiotic-associated Clostridioides difficile infection. Since then, FMT has been actively studied, particularly for its therapeutic potential in ulcerative colitis, a subtype of IBD.
Randomized controlled trials have investigated various methods of FMT delivery in ulcerative colitis, including colonoscopy, sigmoidoscopy, and oral capsules. No significant differences in efficacy have been reported between endoscopic and oral routes. In a domestic study on multidrug-resistant organisms, oral capsules showed promising outcomes in restoring microbial balance when compared with endoscopy and nasogastric tube administration.
While FMT delivery methods in Western countries are evolving from inpatient colonoscopic administration to outpatient enema or capsule-based regimens, South Korea currently lacks clinical research infrastructure for FMT beyond case reports. Although a few cases of FMT in IBD patients have been documented, no center has conducted formal clinical trials.
Therefore, this study aims to evaluate the clinical efficacy and underlying mechanisms of FMT in Korean patients with IBD, especially those with ulcerative colitis. Through this investigation, we seek to clarify the long-term therapeutic potential and safety of fecal microbiota transplantation in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis patient | Experimental | Biological: Fecal microbiota transplantation (FMT)This was a multicenter, prospective study that enrolled patients diagnosed with ulcerative colitis who were aged between 10 and 80 years and had been receiving treatment for at least 3 months. Eligible participants were required to meet all of the following inclusion criteria: 1. age between 10 and 80 years; 2. a disease duration of ulcerative colitis of at least 3 months; 3. mild to moderate disease activity, defined by a Mayo score of 4-10 or a partial Mayo score of 2-7; 4. endoscopic evidence of rectal involvement extending ≥5 cm; and 5. willingness to provide written informed consent for participation in the study. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 10 and 80 years
- History of ulcerative colitis for at least 3 months
- Mild to moderate ulcerative colitis with a Mayo score of 4-10 or a partial Mayo score of 2-7
- Endoscopic evidence of rectal involvement extending at least 5 cm
- Willingness to provide written informed consent for participation in this clinical trial
Key exclusion criteria (13 listed)
- Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12)
- Neutropenia (absolute neutrophil count < 500)
- Pregnancy
- Infectious colitis not caused by Clostridioides difficile
- History of colectomy (excluding appendectomy)
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 |
|---|---|---|
| Fecal microbiota transplantation (FMT)Fecal microbiota transplantation (FMT) will be performed at weeks 0 and 4 of study enrollment by administering approximately 250-300 cc of a multi-donor fecal suspension into the colon via sigmoidoscopy, colonoscopy, or by oral administration of an equivalent amount (4 capsules). | Biological | Ulcerative colitis patient |
Primary outcome
Co-primary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
1. Steroid-free Clinical Response at Week 12 Mayo score ≥3 and ≥30% ↓ from baseline, with rectal bleeding subscore ↓ ≥1 or ≤1, without steroid use. Unit: Participants 2. Steroid-free Clinical Remission at Week 12 Mayo score ≤2 and no subscore >1, without steroid use. Unit: Participants
10 secondary outcomes
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
Co-secondary outcome
Time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
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 12 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fecal microbiota transplantation (FMT) in people with Ulcerative Colitis and Fecal Microbiota Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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: enrolling by invitation, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Co-primary outcome (time frame: The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).). 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 12 Sep 2025.