Clostridium Difficile Infection RecurrenceNCT07261826
Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
An observational study of Clostridium Difficile Infection Recurrence and Ulcerative Colitis (UC), run by Chen QiYi at 1 site in China.
Trial summary
This is a large-scale observational study aiming to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to restore a balanced gut microbiome. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Clostridium Difficile Infection Recurrence, Ulcerative Colitis (UC), Crohn Disease (CD)
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of approximately 4,000 patients who have undergone Fecal Microbiota Transplantation (FMT) at our center. This includes a retrospective cohort of about 3,000 patients treated between January 2017 and August 2025, whose data will be collected from medical records, and a prospective cohort of about 1,000 new patients to be enrolled from September 2025 to June 2028. Participants must be ≥3 years of age and diagnosed with one of the target diseases, including but not limited to recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain extra-intestinal diseases. All participants must have received at least one FMT treatment and have available baseline data. This real-world study aims to include a broad patient population reflective of routine clinical practice.
Who may be able to join
- Diagnosed with one of the target diseases.
- Age ≥ 3 years.
- Have received at least one Fecal Microbiota Transplantation (FMT) treatment.
- Availability of complete baseline and follow-up data for analysis.
- Provide signed informed consent (for the prospective cohort) OR consent for the use of clinical data (for the retrospective cohort).
Who cannot join
- Clinical data is severely missing, making efficacy assessment impossible.
- Presence of severe complications that may jeopardize safety or confound the study results.
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
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Chief, Functional Gastrointestinal Surgery, 86+15896453859, qiyichen2011@163.com
About this study
This is a large-scale observational study aiming to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to restore a balanced gut microbiome.
The study will follow approximately 4,000 patients who have received or will receive FMT for conditions like recurrent C. difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain neurological conditions.
Read more
The main goals are to:
- Assess the disease remission rates at 3 months, 1 year, and 5 years after FMT.
- Monitor the long-term safety and any potential side effects.
- Identify factors that may influence how well a patient responds to the treatment.
This research will use both existing patient data (retrospective cohort) and newly collected data from future patients (prospective cohort). The findings are expected to help improve and standardize FMT treatment for better patient care.
Read the detailed description
This is a single-center, real-world observational study combining retrospective and prospective cohorts to systematically evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT).
The study plans to enroll approximately 4,000 patients who have undergone FMT for a range of diseases, including recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal diseases, and certain extra-intestinal disorders.
The primary objective is to assess the real-world clinical remission rates at 3 months, 1 year, and 5 years post-FMT. Secondary objectives include evaluating long-term safety and adverse events, measuring improvements in quality of life, and exploring factors (such as delivery route, donor selection, and patient characteristics) that predict treatment success. Data will be collected from medical records and through planned follow-up visits. Advanced statistical and machine learning models will be used to analyze the data and build predictive models.
The results of this large-scale study will provide high-quality evidence to support the standardized and precise clinical application of FMT.
- Conditions
- Clostridium Difficile Infection Recurrence, Ulcerative Colitis (UC), Crohn Disease (CD), Irritable Bowel Syndrome (IBS), Chronic Functional Constipation, Chemotherapy-Induced Colitis
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Irritable Bowel Syndrome, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clostridium Difficile Infection Recurrence | Not described | |
| Ulcerative Colitis (UC) | Not described | |
| Crohn Disease (CD) | Not described | |
| Irritable Bowel Syndrome (IBS) | Not described | |
| chronic functional constipation | Not described | |
| Chemotherapy-Induced Colitis | Not described | |
| PD-1 associated enteritis | Not described | |
| Autism Spectrum Disorder | Not described | |
| incomplete intestinal obstruction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-Week Clinical Cure of Recurrent CDI
Percentage of participants with sustained clinical cure at 8 weeks post-treatment, defined as persistent resolution of diarrhea (formed stools <3 times per day) AND a negative test for C. difficile toxin.
Measured: 8 weeks after the final FMT treatment
Treatment Response in Chronic Constipation at 8 Weeks
Percentage of participants meeting all of the following criteria at 8 weeks: >3 complete spontaneous bowel movements per week, Bristol Stool Form Scale (BSFS) type 3-5, and a reduction of >30% in the Patient Assessment of Constipation Symptoms (PAC-SYM) score.
Measured: 8 weeks after the final FMT treatment
Corticosteroid-Free Clinical Remission in IBD at 8 Weeks
Percentage of participants achieving corticosteroid-free clinical remission. For Ulcerative Colitis (UC), defined as a Mayo score ≤2 with no subscore >1. For Crohn's Disease (CD), defined as a Crohn's Disease Activity Index (CDAI) score <150.
Measured: 8 weeks after the final FMT treatment
Symptom Relief in IBS at 3 Months
Percentage of participants experiencing relief of abdominal pain or discomfort related to defecation for 3 consecutive months, with stool consistency rated as Bristol Stool Form Scale (BSFS) type 3-5.
Measured: 3 months after the final FMT treatment
Treatment Response in Autism at 12 Weeks
Percentage of participants meeting the response criteria at Week 12, defined as an Autism Behavior Checklist (ABC) score <31 AND a score of 1 (very much improved) on the Clinical Global Impression-Improvement (CGI-I) scale.
Measured: 12 weeks after the final FMT treatment
Symptom Improvement in Incomplete Bowel Obstruction
Percentage of participants achieving a reduction of >50% in abdominal distension and/or pain, AND weaning off parenteral nutrition.
Measured: 8 weeks after the final FMT treatment
Symptom Resolution in Drug-Induced Enteritis
Percentage of participants achieving symptom resolution, defined as a reduction to CTCAE grade ≤1 (stool frequency increase <4 times per day from baseline, without abdominal pain, hematochezia, or mucus), AND requiring corticosteroids <10 mg prednisone equivalent per day.
Measured: 8 weeks after the final FMT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile Infection RecurrenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chen QiYi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen QiYi, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261826
- Sponsor's protocol ID
- SHSY-IEC-6.0/25K221/P01
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rupnik M, Wilcox MH, Gerding DN. Clostridium difficile infection: new developments in epidemiology and pathogenesis. Nat Rev Microbiol. 2009 Jul;7(7):526-36. doi: 10.1038/nrmicro2164.
PubMed 19528959Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.
PubMed 27329806EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.
PubMed 13592638Zhang 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 23160295Petersen C, Round JL. Defining dysbiosis and its influence on host immunity and disease. Cell Microbiol. 2014 Jul;16(7):1024-33. doi: 10.1111/cmi.12308. Epub 2014 Jun 2.
PubMed 24798552Baumler AJ, Sperandio V. Interactions between the microbiota and pathogenic bacteria in the gut. Nature. 2016 Jul 7;535(7610):85-93. doi: 10.1038/nature18849.
PubMed 27383983Zheng D, Liwinski T, Elinav E. Interaction between microbiota and immunity in health and disease. Cell Res. 2020 Jun;30(6):492-506. doi: 10.1038/s41422-020-0332-7. Epub 2020 May 20.
PubMed 32433595Rowland I, Gibson G, Heinken A, Scott K, Swann J, Thiele I, Tuohy K. Gut microbiota functions: metabolism of nutrients and other food components. Eur J Nutr. 2018 Feb;57(1):1-24. doi: 10.1007/s00394-017-1445-8. Epub 2017 Apr 9.
PubMed 28393285Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.
PubMed 20203603