Solid Organ Transplant ComplicationsNCT06708676
Washed Microbiota Transplantation in Solid Organ Transplantation
A study testing Washed Microbiota Transplantation in people with Solid Organ Transplant Complications, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Organ Transplant Complications
- What is being tested?
- Washed Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 31 Dec 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- solid organ transplantation recipients;
- suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;
- is willing to undergo WMT and provide written informed consent;
Who cannot join
- patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
- pregnant or lactating females;
- unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
- follow up less than 1-month post-WMT;
- other conditions judged by investigators not suitable for study participation;
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
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Faming Zhang, PhD, 086-025-58509883, fzhang@njmu.edu.cn
About this study
Official title: Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation
Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.
- Conditions
- Solid Organ Transplant Complications
- Being tested
- Washed Microbiota Transplantation
- Keywords
- Solid Organ Transplant Complications, Washed microbiota transplantation, Fecal microbiota transplantation, Diarrhea, Clostridium difficile
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Washed Microbiota TransplantationOther
Also called fecal microbiota transplanatation
Washed microbiota suspension delivered through mild-gut and lower-gut
| Study group | Role | What they receive |
|---|---|---|
| Washed Microbiota Transplantation(WMT) | Experimental | Not described Receives: Other: Washed Microbiota Transplantation |
| Basic Treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency and consistency
Stool frequency and consistency will be evaluated according to the Bristol Stool Form Scale (BSFS, ranging from type 1 - type 7)
Measured: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gastrointestinal Symptom Rating Scale (GSRS)
GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
Measured: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Pathogen detection and culture
Pathogen was detected and cultured from serum, urine, stool and so on before and after WMT.
Measured: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Secondary outcomes (3)
Adverse events(AEs)
AEs will be evaluated according to NCI Common Terminology Criteria for Adverse Events(CTCAE), Version 5.0
Measured: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gut microbiota
Changes in intestinal microbial composition and diversity in the stool samples of patients before and after WMT
Measured: Baseline, 3-month post WMT
Quality of life by SF-36
SF-36 is a 36-item questionnaire to assess the impact of disease on daily life. The SF-36 consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). Lower scores represent more dysfunction.
Measured: Baseline, 3-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 posted27 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Solid Organ Transplant ComplicationsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708676
- Sponsor's protocol ID
- WMT-SOT
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu G, Wang W, Li P, Wen Q, Cui B, Zhang F. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery. Microb Biotechnol. 2022 Sep;15(9):2439-2449. doi: 10.1111/1751-7915.14074. Epub 2022 May 16.
PubMed 35576458Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
PubMed 31919742Swarte JC, Douwes RM, Hu S, Vich Vila A, Eisenga MF, van Londen M, Gomes-Neto AW, Weersma RK, Harmsen HJM, Bakker SJL. Characteristics and Dysbiosis of the Gut Microbiome in Renal Transplant Recipients. J Clin Med. 2020 Feb 1;9(2):386. doi: 10.3390/jcm9020386.
PubMed 32024079Cheng YW, Phelps E, Ganapini V, Khan N, Ouyang F, Xu H, Khanna S, Tariq R, Friedman-Moraco RJ, Woodworth MH, Dhere T, Kraft CS, Kao D, Smith J, Le L, El-Nachef N, Kaur N, Kowsika S, Ehrlich A, Smith M, Safdar N, Misch EA, Allegretti JR, Flynn A, Kassam Z, Sharfuddin A, Vuppalanchi R, Fischer M. Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience. Am J Transplant. 2019 Feb;19(2):501-511. doi: 10.1111/ajt.15058. Epub 2018 Aug 31.
PubMed 30085388Swarte JC, Li Y, Hu S, Bjork JR, Gacesa R, Vich Vila A, Douwes RM, Collij V, Kurilshikov A, Post A, Klaassen MAY, Eisenga MF, Gomes-Neto AW, Kremer D, Jansen BH, Knobbe TJ, Berger SP, Sanders JF, Heiner-Fokkema MR, Porte RJ, Cuperus FJC, de Meijer VE, Wijmenga C, Festen EAM, Zhernakova A, Fu J, Harmsen HJM, Blokzijl H, Bakker SJL, Weersma RK. Gut microbiome dysbiosis is associated with increased mortality after solid organ transplantation. Sci Transl Med. 2022 Aug 31;14(660):eabn7566. doi: 10.1126/scitranslmed.abn7566. Epub 2022 Aug 31.
PubMed 36044594Lee JR, Magruder M, Zhang L, Westblade LF, Satlin MJ, Robertson A, Edusei E, Crawford C, Ling L, Taur Y, Schluter J, Lubetzky M, Dadhania D, Pamer E, Suthanthiran M. Gut microbiota dysbiosis and diarrhea in kidney transplant recipients. Am J Transplant. 2019 Feb;19(2):488-500. doi: 10.1111/ajt.14974. Epub 2018 Jul 21.
PubMed 29920927Gabarre P, Loens C, Tamzali Y, Barrou B, Jaisser F, Tourret J. Immunosuppressive therapy after solid organ transplantation and the gut microbiota: Bidirectional interactions with clinical consequences. Am J Transplant. 2022 Apr;22(4):1014-1030. doi: 10.1111/ajt.16836. Epub 2021 Oct 15.
PubMed 34510717
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT06708676
- Acronym / sponsor ID
- WMT-SOT
- Conditions
- Solid Organ Transplant Complications
- Keywords
- Solid Organ Transplant Complications, Washed microbiota transplantation, Fecal microbiota transplantation, Diarrhea, Clostridium difficile
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Nov 2024 (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.
Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washed Microbiota Transplantation(WMT) | Experimental | Other: Washed Microbiota Transplantation |
| Basic Treatment | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- solid organ transplantation recipients;
- suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;
- is willing to undergo WMT and provide written informed consent;
Key exclusion criteria (5 listed)
- patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
- pregnant or lactating females;
- unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
- follow up less than 1-month post-WMT;
- other conditions judged by investigators not suitable for study participation;
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 |
|---|---|---|
| Washed Microbiota TransplantationAlso: fecal microbiota transplanatationWashed microbiota suspension delivered through mild-gut and lower-gut | Other | Washed Microbiota Transplantation(WMT) |
Primary outcome
Stool frequency and consistency
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Stool frequency and consistency will be evaluated according to the Bristol Stool Form Scale (BSFS, ranging from type 1 - type 7)
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
Pathogen detection and culture
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Pathogen was detected and cultured from serum, urine, stool and so on before and after WMT.
3 secondary outcomes
Adverse events(AEs)
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gut microbiota
Time frame: Baseline, 3-month post WMT
Quality of life by SF-36
Time frame: Baseline, 3-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 27 Nov 2024.
- Background: PubMed 35576458Lu G, Wang W, Li P, Wen Q, Cui B, Zhang F. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery. Microb Biotechnol. 2022 Sep;15(9):2439-2449. doi: 10.1111/1751-7915.14074. Epub 2022 May 16.
- Background: PubMed 31919742Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
- Background: PubMed 32024079Swarte JC, Douwes RM, Hu S, Vich Vila A, Eisenga MF, van Londen M, Gomes-Neto AW, Weersma RK, Harmsen HJM, Bakker SJL. Characteristics and Dysbiosis of the Gut Microbiome in Renal Transplant Recipients. J Clin Med. 2020 Feb 1;9(2):386. doi: 10.3390/jcm9020386.
- Background: PubMed 30085388Cheng YW, Phelps E, Ganapini V, Khan N, Ouyang F, Xu H, Khanna S, Tariq R, Friedman-Moraco RJ, Woodworth MH, Dhere T, Kraft CS, Kao D, Smith J, Le L, El-Nachef N, Kaur N, Kowsika S, Ehrlich A, Smith M, Safdar N, Misch EA, Allegretti JR, Flynn A, Kassam Z, Sharfuddin A, Vuppalanchi R, Fischer M. Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience. Am J Transplant. 2019 Feb;19(2):501-511. doi: 10.1111/ajt.15058. Epub 2018 Aug 31.
- Background: PubMed 36044594Swarte JC, Li Y, Hu S, Bjork JR, Gacesa R, Vich Vila A, Douwes RM, Collij V, Kurilshikov A, Post A, Klaassen MAY, Eisenga MF, Gomes-Neto AW, Kremer D, Jansen BH, Knobbe TJ, Berger SP, Sanders JF, Heiner-Fokkema MR, Porte RJ, Cuperus FJC, de Meijer VE, Wijmenga C, Festen EAM, Zhernakova A, Fu J, Harmsen HJM, Blokzijl H, Bakker SJL, Weersma RK. Gut microbiome dysbiosis is associated with increased mortality after solid organ transplantation. Sci Transl Med. 2022 Aug 31;14(660):eabn7566. doi: 10.1126/scitranslmed.abn7566. Epub 2022 Aug 31.
- Background: PubMed 29920927Lee JR, Magruder M, Zhang L, Westblade LF, Satlin MJ, Robertson A, Edusei E, Crawford C, Ling L, Taur Y, Schluter J, Lubetzky M, Dadhania D, Pamer E, Suthanthiran M. Gut microbiota dysbiosis and diarrhea in kidney transplant recipients. Am J Transplant. 2019 Feb;19(2):488-500. doi: 10.1111/ajt.14974. Epub 2018 Jul 21.
- Background: PubMed 34510717Gabarre P, Loens C, Tamzali Y, Barrou B, Jaisser F, Tourret J. Immunosuppressive therapy after solid organ transplantation and the gut microbiota: Bidirectional interactions with clinical consequences. Am J Transplant. 2022 Apr;22(4):1014-1030. doi: 10.1111/ajt.16836. Epub 2021 Oct 15.
- 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, PhD 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?
A study testing Washed Microbiota Transplantation in people with Solid Organ Transplant Complications, 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 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 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 (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency and consistency (time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT). The study lists 3 primary outcomes in all. 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 NCT06708676, which also lists 7 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 27 Nov 2024.