Clostridioides Difficile InfectionNCT06106698
Washed Microbiota Transplantation for Clostridioides Difficile Infection
An observational study of Clostridioides Difficile Infection, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation （WMT） for patients with Clostridioides Difficile Infection （CDI）. Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- WMT
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2023to Dec 2029
- Phase
- Observational
- 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 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: National patients with CDI receiving WMT will be enrolled.
Who may be able to join
- Subjects must meet all of the following inclusion criteria to enter the study:
- At the time of informed consent, male or non-pregnant or non-lactating female.
- The diagnostic criteria for C. difficile infection are met during screening:
- Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea.
- CDI-related diarrhea episodes, i.e., defecation ≥3 times/day for at least two consecutive days with unformed stools (Bristol score 6-7).
- The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
Who cannot join
- Subjects meeting any of the following exclusion criteria must be excluded from the study:
- Subjects with immune deficiencies (such as HIV infection, or neutrophils <0.5×109/L in absolute value, or lymphocytes <0.5×109/L, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g/d of prednisone or equal doses of steroid hormones).
- There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.
- Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.
- Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.
- At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
- According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
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
The second affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Jie Zhang, 58509931
About this study
Official title: Washed Microbiota Transplantation for Clostridioides Difficile Infection: a Real World Research
This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation （WMT） for patients with Clostridioides Difficile Infection （CDI）.
Read the detailed description
At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period （at least for 4-week post-WMT）for safety and efficacy evaluation. Subjects with no response and recurrence will receive salvage therapy, and the extended follow-up period will be performed.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- WMT
- Keywords
- washed microbiota transplantation, Clostridioides Difficile Infection, Intestinal infection, Antibiotic-associated Diarrhea
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WMTOther
Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive one dose of WMT for CDI. During follow-up, those who have non-response or CDI recurrence within 4-week post-WMT will receive rescue WMT.
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Measured: Four-week post-WMT
Secondary outcomes (4)
The complete response rate of CDI-related diarrhea
The complete response of CDI-related diarrhea was defined as there was no diarrhea (1-2 times/day) for at least two consecutive days (normal stool characteristics (Bristol score ≤5) after treatment.
Measured: Four-week post-WMT，eight-week post-WMT
Recurrence rate of CDI-related diarrhea.
Recurrence was defined as the CDI-related diarrhea reappeared, and the Clostridium difficile toxin test was positive after achieving complete response.
Measured: Four-week post-WMT，eight-week post-WMT
Rate of major disease progression in CDI.
Disease progression refers to the worsening of symptoms associated with CDI, including increased diarrhea, toxic megacolon, organ failure, the need for emergency colectomy, and even death.
Measured: One-week post-WMT，Two-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Measured: Eight-week post-WMT，six-month-post-WMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start22 Jul 2023
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (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 Clostridioides Difficile InfectionStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faming Zhang, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106698
- Sponsor's protocol ID
- WMT-RWS-CDI
- Status last verified
- Jul 2023
- First submitted
- 12 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guh AY, Mu Y, Winston LG, Johnston H, Olson D, Farley MM, Wilson LE, Holzbauer SM, Phipps EC, Dumyati GK, Beldavs ZG, Kainer MA, Karlsson M, Gerding DN, McDonald LC; Emerging Infections Program Clostridioides difficile Infection Working Group. Trends in U.S. Burden of Clostridioides difficile Infection and Outcomes. N Engl J Med. 2020 Apr 2;382(14):1320-1330. doi: 10.1056/NEJMoa1910215.
PubMed 32242357Antharam VC, Li EC, Ishmael A, Sharma A, Mai V, Rand KH, Wang GP. Intestinal dysbiosis and depletion of butyrogenic bacteria in Clostridium difficile infection and nosocomial diarrhea. J Clin Microbiol. 2013 Sep;51(9):2884-92. doi: 10.1128/JCM.00845-13. Epub 2013 Jun 26.
PubMed 23804381Pike CM, Theriot CM. Mechanisms of Colonization Resistance Against Clostridioides difficile. J Infect Dis. 2021 Jun 16;223(12 Suppl 2):S194-S200. doi: 10.1093/infdis/jiaa408.
PubMed 33326565Kelly CR, Fischer M, Allegretti JR, LaPlante K, Stewart DB, Limketkai BN, Stollman NH. Correction to: ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol. 2022 Feb 1;117(2):358. doi: 10.14309/ajg.0000000000001529. No abstract available.
PubMed 34658366Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015 May 5;162(9):630-8. doi: 10.7326/M14-2693.
PubMed 25938992Ademe M. Benefits of fecal microbiota transplantation: A comprehensive review. J Infect Dev Ctries. 2020 Oct 31;14(10):1074-1080. doi: 10.3855/jidc.12780.
PubMed 33175698Cammarota G, Ianiro G, Kelly CR, Mullish BH, Allegretti JR, Kassam Z, Putignani L, Fischer M, Keller JJ, Costello SP, Sokol H, Kump P, Satokari R, Kahn SA, Kao D, Arkkila P, Kuijper EJ, Vehreschild MJG, Pintus C, Lopetuso L, Masucci L, Scaldaferri F, Terveer EM, Nieuwdorp M, Lopez-Sanroman A, Kupcinskas J, Hart A, Tilg H, Gasbarrini A. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019 Dec;68(12):2111-2121. doi: 10.1136/gutjnl-2019-319548. Epub 2019 Sep 28.
PubMed 31563878Ng SC, Kamm MA, Yeoh YK, Chan PKS, Zuo T, Tang W, Sood A, Andoh A, Ohmiya N, Zhou Y, Ooi CJ, Mahachai V, Wu CY, Zhang F, Sugano K, Chan FKL. Scientific frontiers in faecal microbiota transplantation: joint document of Asia-Pacific Association of Gastroenterology (APAGE) and Asia-Pacific Society for Digestive Endoscopy (APSDE). Gut. 2020 Jan;69(1):83-91. doi: 10.1136/gutjnl-2019-319407. Epub 2019 Oct 14.
PubMed 31611298van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washed Microbiota Transplantation for Clostridioides Difficile Infection: a Real World Research
- ClinicalTrials.gov ID
- NCT06106698
- Acronym / sponsor ID
- WMT-RWS-CDI
- Conditions
- Clostridioides Difficile Infection
- Keywords
- washed microbiota transplantation, Clostridioides Difficile Infection, Intestinal infection, Antibiotic-associated Diarrhea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Oct 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.
This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation （WMT） for patients with Clostridioides Difficile Infection （CDI）.
Detailed description
At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period （at least for 4-week post-WMT）for safety and efficacy evaluation. Subjects with no response and recurrence will receive salvage therapy, and the extended follow-up period will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- National patients with CDI receiving WMT will be enrolled.
Key inclusion criteria (6 listed)
- At the time of informed consent, male or non-pregnant or non-lactating female.
- The diagnostic criteria for C. difficile infection are met during screening:
- The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
Key exclusion criteria (7 listed)
- Subjects with immune deficiencies (such as HIV infection, or neutrophils <0.5×109/L in absolute value, or lymphocytes <0.5×109/L, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g/d of prednisone or equal doses of steroid hormones).
- There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.
- Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.
- Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.
- At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
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 |
|---|---|---|
| WMTWashed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive one dose of WMT for CDI. During follow-up, those who have non-response or CDI recurrence within 4-week post-WMT will receive rescue WMT. | Other | – |
Primary outcome
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time frame: Four-week post-WMT
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
4 secondary outcomes
The complete response rate of CDI-related diarrhea
Time frame: Four-week post-WMT，eight-week post-WMT
Recurrence rate of CDI-related diarrhea.
Time frame: Four-week post-WMT，eight-week post-WMT
Rate of major disease progression in CDI.
Time frame: One-week post-WMT，Two-week post-WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time frame: Eight-week post-WMT，six-month-post-WMT
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 30 Oct 2023.
- Results publication: PubMed 32242357Guh AY, Mu Y, Winston LG, Johnston H, Olson D, Farley MM, Wilson LE, Holzbauer SM, Phipps EC, Dumyati GK, Beldavs ZG, Kainer MA, Karlsson M, Gerding DN, McDonald LC; Emerging Infections Program Clostridioides difficile Infection Working Group. Trends in U.S. Burden of Clostridioides difficile Infection and Outcomes. N Engl J Med. 2020 Apr 2;382(14):1320-1330. doi: 10.1056/NEJMoa1910215.
- Results publication: PubMed 23804381Antharam VC, Li EC, Ishmael A, Sharma A, Mai V, Rand KH, Wang GP. Intestinal dysbiosis and depletion of butyrogenic bacteria in Clostridium difficile infection and nosocomial diarrhea. J Clin Microbiol. 2013 Sep;51(9):2884-92. doi: 10.1128/JCM.00845-13. Epub 2013 Jun 26.
- Results publication: PubMed 33326565Pike CM, Theriot CM. Mechanisms of Colonization Resistance Against Clostridioides difficile. J Infect Dis. 2021 Jun 16;223(12 Suppl 2):S194-S200. doi: 10.1093/infdis/jiaa408.
- Results publication: PubMed 34658366Kelly CR, Fischer M, Allegretti JR, LaPlante K, Stewart DB, Limketkai BN, Stollman NH. Correction to: ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections. Am J Gastroenterol. 2022 Feb 1;117(2):358. doi: 10.14309/ajg.0000000000001529. No abstract available.
- Results publication: PubMed 25938992Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015 May 5;162(9):630-8. doi: 10.7326/M14-2693.
- Results publication: PubMed 33175698Ademe M. Benefits of fecal microbiota transplantation: A comprehensive review. J Infect Dev Ctries. 2020 Oct 31;14(10):1074-1080. doi: 10.3855/jidc.12780.
- Results publication: PubMed 31563878Cammarota G, Ianiro G, Kelly CR, Mullish BH, Allegretti JR, Kassam Z, Putignani L, Fischer M, Keller JJ, Costello SP, Sokol H, Kump P, Satokari R, Kahn SA, Kao D, Arkkila P, Kuijper EJ, Vehreschild MJG, Pintus C, Lopetuso L, Masucci L, Scaldaferri F, Terveer EM, Nieuwdorp M, Lopez-Sanroman A, Kupcinskas J, Hart A, Tilg H, Gasbarrini A. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019 Dec;68(12):2111-2121. doi: 10.1136/gutjnl-2019-319548. Epub 2019 Sep 28.
- Results publication: PubMed 31611298Ng SC, Kamm MA, Yeoh YK, Chan PKS, Zuo T, Tang W, Sood A, Andoh A, Ohmiya N, Zhou Y, Ooi CJ, Mahachai V, Wu CY, Zhang F, Sugano K, Chan FKL. Scientific frontiers in faecal microbiota transplantation: joint document of Asia-Pacific Association of Gastroenterology (APAGE) and Asia-Pacific Society for Digestive Endoscopy (APSDE). Gut. 2020 Jan;69(1):83-91. doi: 10.1136/gutjnl-2019-319407. Epub 2019 Oct 14.
- Results publication: PubMed 23323867van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- 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.
Faming Zhang principal investigator
The Second 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?
An observational study of Clostridioides Difficile Infection, 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 6 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 30 Oct 2023. 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 Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 (time frame: Four-week post-WMT). 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 NCT06106698, which also lists 9 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 30 Oct 2023.