Irritable Bowel DiseaseNCT06697119
Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Irritable Bowel Syndrome
A study testing Fecal Microbial Transplantation in people with Irritable Bowel Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to assess the efficacy and safety of fecal microbiota transplantation (FMT) for patients with irritable bowel syndrome (IBS). The main objectives of the study are: To determine if FMT can significantly reduce IBS symptoms and improve patients' quality of life. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Irritable Bowel Disease
- What is being tested?
- Fecal Microbial Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2023to 25 Apr 2027
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Korean men and women aged 19 to 80 years
- Diagnosed according to Rome IV criteria, with abdominal pain occurring at least once per week that began more than 6 months prior and has recurred over the past 3 months, accompanied by at least two of the following symptoms: pain related to defecation, changes in stool frequency (increase or decrease), or changes in stool form (looser or harder consistency)
- Patients with moderate to severe IBS (IBS-SSS score of 175 or higher) with diarrhea-predominant, mixed-type, or abdominal bloating as the main symptom, who have not responded to IBS medication therapy for over 3 months
- Patients who have had a colonoscopy within the past 5 years, or those who will undergo a colonoscopy after joining the study, and for whom no structural abnormalities in the colon are identified (records from other hospitals within the past 5 years may be used). *Patients who have undergone a biopsy or polypectomy during colonoscopy and can provide examination results are eligible if deemed appropriate by the clinician
- Females who are surgically infertile or females of childbearing potential with a negative pregnancy test (urine hCG or serum b-hCG); females of childbearing potential or males who agree to use effective contraception (e.g., oral contraceptives, IUD, double-barrier methods, or hormonal implants) during the study period
- Individuals capable of clearly expressing their intentions without significant neurological or psychiatric issues. Those with neurological or psychiatric conditions may participate if deemed stable with appropriate medication or other treatments
- Patients who voluntarily provide written informed consent to participate in the study
Who cannot join
- Pregnant or breastfeeding women
- Patients who have received investigational drugs within 3 months prior to Visit 1 (if investigational drugs were used within 3 months, consult the study monitor for case-by-case assessment)
- Patients whom the investigator deems to be at risk or to have conditions that would interfere with participation in the clinical trial
- Patients with severe congestive heart failure or severe angina
- Patients diagnosed with lactose intolerance or those who are immunocompromised
- Patients currently taking medications that may affect the study drug (e.g., intestinal drugs, probiotics), or those who need to continue these medications during the study period. Patients who are currently on these medications can participate after a 2-week washout period
Show all 14Show fewer
- Patients whose systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg at Visit 1, with uncontrolled hypertension regardless of treatment status
- Patients with uncontrolled endocrine disorders (e.g., diabetes), metabolic disorders (e.g., secondary hyperlipidemia), or hypothyroidism. Patients with a history of hypothyroidism may participate if they have been on a stable thyroid hormone replacement therapy for at least 4 weeks before Visit 2 and have a TSH level within the normal range at Visit 2
- Patients with impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome at Visit 1
- Patients with a history of cancer within the last 5 years (except for those deemed cured)
- Patients with significant psychiatric instability or psychiatric disorders not adequately controlled with medication or other treatment
- Patients who have taken systemic steroid medications within 1 month prior to Visit 1
- Patients who have undergone abdominal surgery other than appendectomy, cholecystectomy, cesarean section, hernia repair, or hysterectomy. *Patients with other abdominal surgeries may still participate if deemed eligible by the investigator
- Any other patient whom the investigator deems unsuitable for the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
The goal of this clinical trial is to assess the efficacy and safety of fecal microbiota transplantation (FMT) for patients with irritable bowel syndrome (IBS). The main objectives of the study are:
To determine if FMT can significantly reduce IBS symptoms and improve patients' quality of life.
Read more
To evaluate any potential adverse effects associated with FMT in IBS patients. Researchers will compare outcomes in patients receiving FMT with a standard care protocol to gauge the effectiveness of FMT in alleviating IBS symptoms.
Participants will:
Receive FMT via endoscopic methods as per the study protocol. Attend scheduled clinic visits for assessments and symptom tracking over a 48-week period, with optional long-term follow-up for up to 3 years.
Complete regular questionnaires and microbiota assessments to monitor symptoms and gut health changes over time.
- Conditions
- Irritable Bowel Disease
- Being tested
- Fecal Microbial Transplantation
- Keywords
- fecal microbiota transplantation, FMT, IBS, Irritable bowel disease
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationOther
Fecal suspension is delivered to duodenal 3rd portion via esophagogastroduodenoscopy
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Fecal microbiota transplantation: fecal suspension delivered to duodenal 3rd portion via esophagogastroduodenoscopy Receives: Other: Fecal Microbial Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of IBS-SSS
At 12 weeks post-FMT, overall satisfaction with the improvement in IBS symptoms will be evaluated, alongside changes in the IBS Symptom Severity Score (IBS-SSS) to comprehensively assess the effects of FMT on individual IBS symptoms.
Measured: 12weeks after FMT
Secondary outcomes (5)
Change in IBS-SSS
Change in IBS-SSS Score for IBS Patients (evaluated by the IBS-SSS questionnaire)
Measured: 4 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Stool Frequency and Form
Changes in Stool Frequency and Form for IBS Patients (evaluated by the BSFS questionnaire)
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Quality of Life
Changes in Quality of Life for IBS Patients (evaluated by the IBS-QoL questionnaire)
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Anxiety and Derpession
Changes in Mental Health for IBS Patients (evaluated by the HADS questionnaire)
Measured: 4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in gut microbiota
Differences in Gut Microbiota Between Responders and Non-Responders
Measured: at baseline, 4 weeks, and 12 weeks after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start9 Mar 2023
- Primary completion3 Jul 2024
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697119
- Sponsor's protocol ID
- B-2210-784-004
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu J, Lv L, Wang C. Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials. Front Cell Infect Microbiol. 2022 Feb 28;12:827395. doi: 10.3389/fcimb.2022.827395. eCollection 2022.
PubMed 35295757El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
PubMed 31852769Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17.
PubMed 31326345Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
PubMed 29980607Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15.
PubMed 32681922
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06697119
- Acronym / sponsor ID
- B-2210-784-004
- Conditions
- Irritable Bowel Disease
- Keywords
- fecal microbiota transplantation, FMT, IBS, Irritable bowel disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 20 Nov 2024 (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 assess the efficacy and safety of fecal microbiota transplantation (FMT) for patients with irritable bowel syndrome (IBS). The main objectives of the study are:
To determine if FMT can significantly reduce IBS symptoms and improve patients' quality of life.
To evaluate any potential adverse effects associated with FMT in IBS patients. Researchers will compare outcomes in patients receiving FMT with a standard care protocol to gauge the effectiveness of FMT in alleviating IBS symptoms.
Participants will:
Receive FMT via endoscopic methods as per the study protocol. Attend scheduled clinic visits for assessments and symptom tracking over a 48-week period, with optional long-term follow-up for up to 3 years.
Complete regular questionnaires and microbiota assessments to monitor symptoms and gut health changes over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Other: Fecal Microbial TransplantationFecal microbiota transplantation: fecal suspension delivered to duodenal 3rd portion via esophagogastroduodenoscopy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Korean men and women aged 19 to 80 years
- Diagnosed according to Rome IV criteria, with abdominal pain occurring at least once per week that began more than 6 months prior and has recurred over the past 3 months, accompanied by at least two of the following symptoms: pain related to defecation, changes in stool frequency (increase or decrease), or changes in stool form (looser or harder consistency)
- Patients with moderate to severe IBS (IBS-SSS score of 175 or higher) with diarrhea-predominant, mixed-type, or abdominal bloating as the main symptom, who have not responded to IBS medication therapy for over 3 months
- Patients who have had a colonoscopy within the past 5 years, or those who will undergo a colonoscopy after joining the study, and for whom no structural abnormalities in the colon are identified (records from other hospitals within the past 5 years may be used). *Patients who have undergone a biopsy or polypectomy during colonoscopy and can provide examination results are eligible if deemed appropriate by the clinician
- Females who are surgically infertile or females of childbearing potential with a negative pregnancy test (urine hCG or serum b-hCG); females of childbearing potential or males who agree to use effective contraception (e.g., oral contraceptives, IUD, double-barrier methods, or hormonal implants) during the study period
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women
- Patients who have received investigational drugs within 3 months prior to Visit 1 (if investigational drugs were used within 3 months, consult the study monitor for case-by-case assessment)
- Patients whom the investigator deems to be at risk or to have conditions that would interfere with participation in the clinical trial
- Patients with severe congestive heart failure or severe angina
- Patients diagnosed with lactose intolerance or those who are immunocompromised
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 Microbial TransplantationFecal suspension is delivered to duodenal 3rd portion via esophagogastroduodenoscopy | Other | FMT |
Primary outcome
Changes of IBS-SSS
Time frame: 12weeks after FMT
At 12 weeks post-FMT, overall satisfaction with the improvement in IBS symptoms will be evaluated, alongside changes in the IBS Symptom Severity Score (IBS-SSS) to comprehensively assess the effects of FMT on individual IBS symptoms.
5 secondary outcomes
Change in IBS-SSS
Time frame: 4 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Stool Frequency and Form
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Quality of Life
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in Anxiety and Derpession
Time frame: 4 weeks, 12 weeks, 24 weeks, 48 weeks, 2 years, and 3 years after FMT
Changes in gut microbiota
Time frame: at baseline, 4 weeks, and 12 weeks after FMT
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 20 Nov 2024.
- Background: PubMed 35295757Wu J, Lv L, Wang C. Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials. Front Cell Infect Microbiol. 2022 Feb 28;12:827395. doi: 10.3389/fcimb.2022.827395. eCollection 2022.
- Background: PubMed 31852769El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.
- Background: PubMed 31326345Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17.
- Background: PubMed 29980607Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.
- Background: PubMed 32681922Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 study testing Fecal Microbial Transplantation in people with Irritable Bowel Disease, 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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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.
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?
Changes of IBS-SSS (time frame: 12weeks after FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06697119, which also lists 5 linked publications.
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 20 Nov 2024.