BacteriaPhase 2/3NCT01790061
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
A Phase 2/3 study testing Standardized FMT and Traditional treatments in people with Bacteria and Microbiota, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Bacteria, Microbiota, Fecal Microbiota Transplantation
- What is being tested?
- Standardized FMT and Traditional treatments
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.
Who cannot join
- Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.
Trial locations and contacts
1 site in 1 country.
Faming Zhang, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).
Read the detailed description
The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.
- Conditions
- Bacteria, Microbiota, Fecal Microbiota Transplantation, Inflammatory Bowel Disease, Ulcerative Colitis
- Being tested
- Standardized FMT, Traditional treatments
- Keywords
- Gut bacteria, Gut flora, Bacteriotherapy, Fecal Microbiota Transplantation, Inflammatory bowel disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized FMTProcedure or surgery
Also called Fecal Microbiota Transplantation, Fecal Microbiota Therapy, fecal transplantation
Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon
Traditional treatmentsDrug
Also called Traditional treatments according to associated guidelines
Medications
| Study group | Role | What they receive |
|---|---|---|
| Standardized FMT | Experimental | endoscopy Tubing Once or repeat Receives: Procedure: Standardized FMT |
| Traditional treatments | Experimental | Oral Tubing Receives: Drug: Traditional treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of FMT
The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)
Measured: On year
Secondary outcomes (5)
Adverse events
Number and severity of adverse events
Measured: Ten years
sleep quality evaluated by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI), which consisted of 19 items divided into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.Each component received a value from 0 to 3 and the total scores ranged from 0 to 21, with higher scores indicating poorer sleep quality. Poor sleep quality was defined as total PSQI scores > 5.
Measured: before FMT, 1 month and 12 weeks after FMT
sleep quality evaluated by the Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) was used to evaluate the severity of insomnia, which was composed of 7 items. Each item scored from 0-4, with a total score ranging from 0 to 28. High scores indicated poorer sleep quality. ISI ≥ 8 was set as a subthreshold to clinical insomnia.
Measured: before FMT, 1 month and 12 weeks after FMT
anxiety and depression evaluated by the Hospital Anxiety and Depression Scale (HADS)
It had 14 items, 7 each for depression (HADS-D) and anxiety (HADS-A). The total scores ranged from 0 to 21 for HADS-D or HADS-A, with higher score indicating more severe depression or anxiety symptoms. A HADS-A or HADS-D score ≥ 8 was identified as a diagnostic threshold for anxiety or depression in this study.
Measured: before FMT, 1 month and 12 weeks after FMT
fatigue evaluated by the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
FACIT-F was composed of 13 questions, each with a score of 0-4. Total score ranged from 0 to 52, with lower score suggesting greater fatigue. Fatigue remission was defined as FACIT-F score > 40 after FMT and an increase in the FACIT-F score ≥ 4 indicated fatigue improvement according to the previous study.
Measured: before FMT, 1 month 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 posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for BacteriaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Huijie Zhang, MD,PhD, Study chair, The Second Afiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790061
- Sponsor's protocol ID
- FMT-CN-121123
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2013
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244.
PubMed 22183182Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
PubMed 23041678Zhang F, Luo W, Shi Y, Fan Z, Ji G. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol. 2012 Nov;107(11):1755; author reply p.1755-6. doi: 10.1038/ajg.2012.251. No abstract available.
PubMed 23160295Bennet JD, Brinkman M. Treatment of ulcerative colitis by implantation of normal colonic flora. Lancet. 1989 Jan 21;1(8630):164. doi: 10.1016/s0140-6736(89)91183-5. No abstract available.
PubMed 2563083Lu G, Zhang S, Wang R, Wu X, Chen Y, Wen Q, Cui B, Zhang F, Li P. Fecal microbiota transplantation improves bile acid malabsorption in patients with inflammatory bowel disease: results of microbiota and metabolites from two cohort studies. BMC Med. 2025 Sep 1;23(1):511. doi: 10.1186/s12916-025-04353-y.
PubMed 40890737Zhang S, Lu G, Wang W, Li Q, Wang R, Zhang Z, Wu X, Liang C, Liu Y, Li P, Wen Q, Cui B, Zhang F. A predictive machine-learning model for clinical decision-making in washed microbiota transplantation on ulcerative colitis. Comput Struct Biotechnol J. 2024 Aug 24;24:583-592. doi: 10.1016/j.csbj.2024.08.021. eCollection 2024 Dec.
PubMed 39281978Li Q, Liu Y, Zhang Z, Zhang S, Ding X, Zhang F. Washed Microbiota Transplantation Improves the Sleep Quality in Patients with Inflammatory Bowel Disease. Nat Sci Sleep. 2024 Aug 2;16:1141-1152. doi: 10.2147/NSS.S460882. eCollection 2024.
PubMed 39109266Zhang T, Li P, Wu X, Lu G, Marcella C, Ji X, Ji G, Zhang F. Alterations of Akkermansia muciniphila in the inflammatory bowel disease patients with washed microbiota transplantation. Appl Microbiol Biotechnol. 2020 Dec;104(23):10203-10215. doi: 10.1007/s00253-020-10948-7. Epub 2020 Oct 16.
PubMed 33064186Li Q, Ding X, Liu K, Marcella C, Liu X, Zhang T, Liu Y, Li P, Xiang L, Cui B, Wang J, Bai J, Zhang F. Fecal Microbiota Transplantation for Ulcerative Colitis: The Optimum Timing and Gut Microbiota as Predictors for Long-Term Clinical Outcomes. Clin Transl Gastroenterol. 2020 Aug;11(8):e00224. doi: 10.14309/ctg.0000000000000224.
PubMed 32955197Li Q, Zhang T, Ding X, Xiang L, Cui B, Buch H, Zhang F. Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):955-962. doi: 10.1097/MEG.0000000000001725.
PubMed 32282545Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.
PubMed 30972640Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
PubMed 26363929
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01790061
- Acronym / sponsor ID
- FMT-CN-121123
- Conditions
- Bacteria, Microbiota, Fecal Microbiota Transplantation, Inflammatory Bowel Disease, Ulcerative Colitis
- Keywords
- Gut bacteria, Gut flora, Bacteriotherapy, Fecal Microbiota Transplantation, Inflammatory bowel disease, Ulcerative colitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 2013 (estimated)
- 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 gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).
Detailed description
The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized FMT | Experimental | Procedure: Standardized FMTendoscopy Tubing Once or repeat |
| Traditional treatments | Experimental | Drug: Traditional treatmentsOral Tubing |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.
Key exclusion criteria (1 listed)
- Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.
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 |
|---|---|---|
| Standardized FMTAlso: Fecal Microbiota Transplantation, Fecal Microbiota Therapy, fecal transplantationFecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon | Procedure or surgery | Standardized FMT |
| Traditional treatmentsAlso: Traditional treatments according to associated guidelinesMedications | Drug | Traditional treatments |
Primary outcome
Efficacy of FMT
Time frame: On year
The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)
5 secondary outcomes
Adverse events
Time frame: Ten years
sleep quality evaluated by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: before FMT, 1 month and 12 weeks after FMT
sleep quality evaluated by the Insomnia Severity Index (ISI)
Time frame: before FMT, 1 month and 12 weeks after FMT
anxiety and depression evaluated by the Hospital Anxiety and Depression Scale (HADS)
Time frame: before FMT, 1 month and 12 weeks after FMT
fatigue evaluated by the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
Time frame: before FMT, 1 month and 12 weeks after FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 22183182Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244.
- Background: PubMed 23041678Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
- Background: PubMed 23160295Zhang F, Luo W, Shi Y, Fan Z, Ji G. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol. 2012 Nov;107(11):1755; author reply p.1755-6. doi: 10.1038/ajg.2012.251. No abstract available.
- Background: PubMed 2563083Bennet JD, Brinkman M. Treatment of ulcerative colitis by implantation of normal colonic flora. Lancet. 1989 Jan 21;1(8630):164. doi: 10.1016/s0140-6736(89)91183-5. No abstract available.
- Derived from this study: PubMed 40890737Lu G, Zhang S, Wang R, Wu X, Chen Y, Wen Q, Cui B, Zhang F, Li P. Fecal microbiota transplantation improves bile acid malabsorption in patients with inflammatory bowel disease: results of microbiota and metabolites from two cohort studies. BMC Med. 2025 Sep 1;23(1):511. doi: 10.1186/s12916-025-04353-y.
- Derived from this study: PubMed 39281978Zhang S, Lu G, Wang W, Li Q, Wang R, Zhang Z, Wu X, Liang C, Liu Y, Li P, Wen Q, Cui B, Zhang F. A predictive machine-learning model for clinical decision-making in washed microbiota transplantation on ulcerative colitis. Comput Struct Biotechnol J. 2024 Aug 24;24:583-592. doi: 10.1016/j.csbj.2024.08.021. eCollection 2024 Dec.
- Derived from this study: PubMed 39109266Li Q, Liu Y, Zhang Z, Zhang S, Ding X, Zhang F. Washed Microbiota Transplantation Improves the Sleep Quality in Patients with Inflammatory Bowel Disease. Nat Sci Sleep. 2024 Aug 2;16:1141-1152. doi: 10.2147/NSS.S460882. eCollection 2024.
- Derived from this study: PubMed 33064186Zhang T, Li P, Wu X, Lu G, Marcella C, Ji X, Ji G, Zhang F. Alterations of Akkermansia muciniphila in the inflammatory bowel disease patients with washed microbiota transplantation. Appl Microbiol Biotechnol. 2020 Dec;104(23):10203-10215. doi: 10.1007/s00253-020-10948-7. Epub 2020 Oct 16.
- Derived from this study: PubMed 32955197Li Q, Ding X, Liu K, Marcella C, Liu X, Zhang T, Liu Y, Li P, Xiang L, Cui B, Wang J, Bai J, Zhang F. Fecal Microbiota Transplantation for Ulcerative Colitis: The Optimum Timing and Gut Microbiota as Predictors for Long-Term Clinical Outcomes. Clin Transl Gastroenterol. 2020 Aug;11(8):e00224. doi: 10.14309/ctg.0000000000000224.
- Derived from this study: PubMed 32282545Li Q, Zhang T, Ding X, Xiang L, Cui B, Buch H, Zhang F. Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):955-962. doi: 10.1097/MEG.0000000000001725.
- Derived from this study: PubMed 30972640Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.
- Derived from this study: PubMed 26363929Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
- Fecal microbiota transplantationLink provided by the sponsor.
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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.
Faming Zhang, MD,PhD contact
Huijie Zhang, MD,PhD study chair
The Second Afiliated Hospital of Nanjing Medical University
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 Standardized FMT and Traditional treatments in people with Bacteria and Microbiota, run by The Second Hospital of Nanjing Medical University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 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 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD,PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of FMT (time frame: On year). 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 NCT01790061, which also lists 12 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 19 Apr 2024.