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Inflammatory Bowel DiseaseNCT01793831

Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

A study testing FMT in people with Inflammatory Bowel Disease and Crohn's Disease (CD), run by The Second Hospital of Nanjing Medical University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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?
Any age
What is being tested?
FMT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
2 sitesChina
Study dates
Feb 2013to Dec 2025
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.
  • Willingness to undergo FMT (Fecal Microbiota Transplantation).

Who cannot join

  • Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).

Trial locations and contacts

2 sites in 1 country.

Faming Zhang, MD, PhD contact

86-025-58509883

fzhang@njmu.edu.cn

Huijie Zhang, MD, PhD contact

86-025-58509670

zhjssm@163.com

China2 sites, 2 recruiting

  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

    Huai'an, Jiangsu, 223000

    Honggang Wang, MD, 86-18851268720, jgzwhg@njmu.edu.cn

    Recruiting

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

    Faming Zhang, MD, PhD, 86-025-58509883, fzhang@njmu.edu.cn

    Faming Zhang

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases

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 fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

Read the detailed description

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI>4). We established a standard microbiota isolation from donated fresh stool in lab. The microbiota is then transplanted into the intestine via endoscopy or other established methods, such as mid-gut or colonic transendoscopic enteral tubing. Patients from multi-clinical centers in this study will be assigned to receive FMT or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, imaging, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Being tested
FMT
Keywords
Inflammatory bowel disease, Fecal transplantation, Fecal bacteriotherapy, Fecal microbiota transplantation, Crohn's disease
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMTProcedure or surgery

    Standard FMT

Study groups in NCT01793831
Study groupRoleWhat they receive
Fecal microbiota transplantationExperimentalStandard fecal microbiota transplantation, which has been defined as washed microbiota transplantation since 2019.
Receives: Procedure: FMT
Traditional treatmentsNo interventionTraditional treatments for Crohn's disease and its complications according to the guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical remission

    Clinical remission defined as HBI score ≦ 4. For patients with complications such as intestinal obstruction, Clinical remission can be defined as obstruction improvement. The endpoint of follow-up is the time of clinical recurrence.

    Measured: Up to one year

Secondary outcomes (6)

  1. Costs

    Social and medical costs

    Measured: Up to one year

  2. Adverse events

    All possible adverse events:fever,abdominal pain,infectious diseases and others

    Measured: During FMT and ten years after FMT

  3. Sleep quality

    evaluated by Pittsburgh Sleep Quality Index (PSQI), with a score range of 0 to 21. Higher PSQI score indicates poorer sleep quality. Insomnia Severity Index (ISI), with a score range of 0 to 28. Higher ISI score indicates more severe insomnia.

    Measured: before FMT, 1 month after FMT, 12 weeks after FMT

  4. Fatigue

    evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), with a score range of 0 to 52. Higher FACIT-F score indicates lower levels of fatigue and better quality of life.

    Measured: before FMT, 1 month after FMT, 12 weeks after FMT

  5. Anxiety and depression

    evaluated by Hospital Anxiety and Depression Scale (HADS), with a score range of 0 to 42. Higher scores indicate greater severity of anxiety and depression symptoms.

    Measured: before FMT, 1 month after FMT, 12 weeks after FMT

  6. Symptomatic stricture

    evaluated by Crohn's Disease Obstruction Score (CDOS), with a score range of 0 to 6. Higher scores indicate greater severity of obstructive symptoms.

    Measured: before FMT, 1 month after FMT, 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.

  1. First posted18 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01793831
Sponsor's protocol ID
FMC-CN-121101
Status last verified
Aug 2024
First submitted
13 Feb 2013
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93.

    PubMed 23034604

  • Aroniadis 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 23041678

  • Zhang FM, Wang HG, Wang M, Cui BT, Fan ZN, Ji GZ. Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. World J Gastroenterol. 2013 Nov 7;19(41):7213-6. doi: 10.3748/wjg.v19.i41.7213.

    PubMed 24222969

  • Zhang T, Xiang J, Cui B, He Z, Li P, Chen H, Xu L, Ji G, Nie Y, Wu K, Fan D, Huang G, Bai J, Zhang F. Cost-effectiveness analysis of fecal microbiota transplantation for inflammatory bowel disease. Oncotarget. 2017 Oct 4;8(51):88894-88903. doi: 10.18632/oncotarget.21491. eCollection 2017 Oct 24.

    PubMed 29179485

  • He Z, Li P, Zhu J, Cui B, Xu L, Xiang J, Zhang T, Long C, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Multiple fresh fecal microbiota transplants induces and maintains clinical remission in Crohn's disease complicated with inflammatory mass. Sci Rep. 2017 Jul 6;7(1):4753. doi: 10.1038/s41598-017-04984-z.

    PubMed 28684845

  • Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.

    PubMed 25168749

  • Lu 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 40890737

  • Li 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 39109266

  • Li Q, Ding X, Liu Y, Marcella C, Dai M, Zhang T, Bai J, Xiang L, Wen Q, Cui B, Zhang F. Fecal Microbiota Transplantation is a Promising Switch Therapy for Patients with Prior Failure of Infliximab in Crohn's Disease. Front Pharmacol. 2021 May 17;12:658087. doi: 10.3389/fphar.2021.658087. eCollection 2021.

    PubMed 34079458

  • Zhang 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 33064186

  • Xiang L, Ding X, Li Q, Wu X, Dai M, Long C, He Z, Cui B, Zhang F. Efficacy of faecal microbiota transplantation in Crohn's disease: a new target treatment? Microb Biotechnol. 2020 May;13(3):760-769. doi: 10.1111/1751-7915.13536. Epub 2020 Jan 20.

    PubMed 31958884

  • Li P, Zhang T, Xiao Y, Tian L, Cui B, Ji G, Liu YY, Zhang F. Timing for the second fecal microbiota transplantation to maintain the long-term benefit from the first treatment for Crohn's disease. Appl Microbiol Biotechnol. 2019 Jan;103(1):349-360. doi: 10.1007/s00253-018-9447-x. Epub 2018 Oct 24.

    PubMed 30357440

Questions about this trial

What is this clinical trial studying?

A study testing FMT in people with Inflammatory Bowel Disease and Crohn's Disease (CD), run by The Second Hospital of Nanjing Medical University at 2 sites 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 2 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 29 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 2 sites 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?

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 (86-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical remission (time frame: Up to one 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 NCT01793831, 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 29 Nov 2024.

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