Irritable Bowel SyndromeNCT05740319
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
A study testing FMT in people with Irritable Bowel Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- FMT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 31 Dec 2026
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
- Patients who have experienced failure of at least 3 conventional therapies for IBS;
- Absence of red flags such as weight loss, hematochezia;
Who cannot join
- Pregnant, planning pregnancy or lactating;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- Immunodeficiency or treatment with immune-modulating medication;
- Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
- Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
- Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Shengdi Wu, (86)13817923359, wu.shengdi@zs-hospital.sh.cn
About this study
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
Read the detailed description
This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- FMT
- 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.
FMTOther
FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Participants will be given FMT through oral capsules or nasojejunal tube once a month for three months. Receives: Other: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks
IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and 9 weeks (after three-time FMT).
Measured: at baseline and 9 weeks
Response rate at 9 weeks
Investigator ask participants a single question, "Compared to the way you felt before you entered the study, have you IBS symptoms over the past 7 days been: 1)"Substantially Worse"; 2)"Moderately Worse"; 3) Slightly Worse; 4)"No Change"; 5) Slightly Improved"; 6) Moderately Improved"; 7) Substantially Improved". Responder is defined as participants who report "moderately improved" or "substantially improved".
Measured: at 9 weeks
Secondary outcomes (8)
Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months
IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and at 1 week (after first FMT), 1 month (three weeks after first FMT), and 6 months (4 months after three-time FMT).
Measured: at baseline, 1 week, 1 month and 6 months
Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months
Gastrointestinal symptom rating scale (GSRS) is used to evaluate change in gastrointestinal symptoms, with a score ranging from 15 to 105. Higher score means severer gastrointestinal symptoms. Change in IBS-SSS score is obtained by evaluating the scale at baseline, 1 week (after first FMT), 1 month (three weeks after first FMT), 9 weeks (after three-time FMT) and 6 months (4 months after three-time FMT).
Measured: at baseline, 1 week, 1 month, 9 weeks and 6 months
Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months
IBS-Quality of Life (IBS-QoL) is a specific scale used to evaluate change in quality of life, with a score ranging from 0 to 100. Higher score indicates worse quality of life. Change in IBS-QoL score is obtained by evaluating the scale at baseline, 1 month (three weeks after first FMT), 3 months (three weeks after third FMT) and 6 months (4 months after three-time FMT). An over-14-point reduction is considered a significant improvement in quality of life.
Measured: at baseline, 1 month, 3months and 6 months
Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months
Self-rating Anxiety Scale (SAS) is used to evaluate change in IBS-related anxiety, with a score ranging from 25 to 100. Higher score indicates higher level of anxiety. Change in SAS score is obtained by evaluating the scale at baseline, 1 month (three weeks after first FMT), 3 months (three weeks after third FMT) and 6 months (4 months after three-time FMT).
Measured: at baseline, 1 month, 3months and 6 months
Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months
Self-rating Depression Scale (SDS) is used to evaluate change in IBS-related depression, with a score ranging from 25 to 100. Higher score indicates higher level of depression. Change in SDS score is obtained by evaluating the scale at baseline, 1 month (three weeks after first FMT), 3 months (three weeks after third FMT) and 6 months (4 months after three-time FMT).
Measured: at baseline, 1 month, 3months and 6 months
Response rate at 1 week, 1month, 3 months and 6 months
Investigator ask participants a single question, "Compared to the way you felt before you entered the study, have you IBS symptoms over the past 7 days been: 1)"Substantially Worse"; 2)"Moderately Worse"; 3) Slightly Worse; 4)"No Change"; 5) Slightly Improved"; 6) Moderately Improved"; 7) Substantially Improved". Responder is defined as participants who report "moderately improved" or "substantially improved".
Measured: at 1 week, 1month, 3 months and 6 months
Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months
Fecal samples are collected at baseline, 1 week (after first FMT), 1 month (three weeks after first FMT) and 6 months (4 months after three-time FMT). Change in fecal microbiota was measured by 16S rRNA sequencing and metagenomics.
Measured: at baseline, 1 week, 1 month and 6 months
Change from baseline fecal metabolites at 1 week, 1 month and 6 months
Fecal samples are collected at baseline, 1 week (after first FMT), 1 month (three weeks after first FMT) and 6 months (4 months after three-time FMT). Change in fecal metabolites are measured by untargeted metabolomics.
Measured: at baseline, 1 week, 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start10 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Dong, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740319
- Sponsor's protocol ID
- B2022-507R
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05740319
- Acronym / sponsor ID
- B2022-507R
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Feb 2023 (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.
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
Detailed description
This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition.
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: FMTParticipants will be given FMT through oral capsules or nasojejunal tube once a month for three months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
- Patients who have experienced failure of at least 3 conventional therapies for IBS;
- Absence of red flags such as weight loss, hematochezia;
Key exclusion criteria (7 listed)
- Pregnant, planning pregnancy or lactating;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- Immunodeficiency or treatment with immune-modulating medication;
- Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
- Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
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 |
|---|---|---|
| FMTFMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube. | Other | FMT |
Primary outcome
Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks
Time frame: at baseline and 9 weeks
IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and 9 weeks (after three-time FMT).
Response rate at 9 weeks
Time frame: at 9 weeks
Investigator ask participants a single question, "Compared to the way you felt before you entered the study, have you IBS symptoms over the past 7 days been: 1)"Substantially Worse"; 2)"Moderately Worse"; 3) Slightly Worse; 4)"No Change"; 5) Slightly Improved"; 6) Moderately Improved"; 7) Substantially Improved". Responder is defined as participants who report "moderately improved" or "substantially improved".
8 secondary outcomes
Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months
Time frame: at baseline, 1 week, 1 month and 6 months
Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months
Time frame: at baseline, 1 week, 1 month, 9 weeks and 6 months
Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months
Time frame: at baseline, 1 month, 3months and 6 months
Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months
Time frame: at baseline, 1 month, 3months and 6 months
Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months
Time frame: at baseline, 1 month, 3months and 6 months
Response rate at 1 week, 1month, 3 months and 6 months
Time frame: at 1 week, 1month, 3 months and 6 months
Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months
Time frame: at baseline, 1 week, 1 month and 6 months
Change from baseline fecal metabolites at 1 week, 1 month and 6 months
Time frame: at baseline, 1 week, 1 month and 6 months
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 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ling Dong principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT in people with Irritable Bowel Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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 China. 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?
Contact Shengdi Wu ((86)13817923359, wu.shengdi@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks (time frame: at baseline and 9 weeks). 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 25 Feb 2026.