Clostridium InfectionsMicroTransNCT02681068
MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
An observational study of Clostridium Infections, run by University of Cologne at 1 site in Germany.
Trial summary
The registry collects cases of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to analyze the safety and effectiveness of FMT. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clostridium Infections
- What is being tested?
- Fecal microbiota transplantation (FMT)
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Dec 2019
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent Clostridium difficile infection
Who may be able to join
- Patients with Clostridium difficile associated diarrhea
Who cannot join
- Patients < 18 years old
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, 50937
Maria Vehreschild, MD, +49 221 478 88794, maria.vehreschild@uk-koeln.de
About this study
The registry collects cases of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to implement a standardization of FMT in German hospitals and improve patient outcome. Therefore, a detailed description of completions of FMT are documented on our web-based survey platform www.ClinicalSurveys.net.
Read the detailed description
Concerning the documentation of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD), physicians from all German hospitals performing a FMT are invited to provide prospective and retrospective information on these cases. Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.
The following data items are retrospectively or prospectively documented into our database, depending on if a informed consent exists or not:
- Patient characteristics (age, gender, weight, height, underlying disease)
- Indication for FMT
- Administration of antibiotics, chemotherapy, and immunosuppression prior to FMT
- Bowel movement prior to FMT
- Screening prior to FMT
- Description concerning completion of FMT
- Basic informations of the donor
- Outcome
- Prospective long term follow up (10 days, four weeks, three months, six months, and 24 months)
The following two differences of data documentation are observed:
- Retrospective data documentation: Data of patients without an informed consent are documented strictly retrospectively after completion of the FMT. No pseudonymization of patient data is carried out so that no re-identification is possible.
- Prospective data documentation:
Data of patients with an informed consent prior to FMT are documented prospectively. A pseudonymization of patient data allows a post-FMT contact (by writing or phone) to patients with respect to the 10 days, four weeks, three months, six months,and 24 months follow-up.
- Conditions
- Clostridium Infections
- Being tested
- Fecal microbiota transplantation (FMT)
- Keywords
- Fecal microbiota transplantation (FMT), Clostridium difficile associated diarrhea (CDAD)
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Other
Fecal microbiota transplantation (FMT) for patients with Clostridium difficile associated diarrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT)
A 24 month follow-up allows analyses of long-term effects of FMT
Measured: 24 months after FMT
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
A 24 month follow-up allows analyses of long-term effects of FMT
Measured: 24 months after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clostridium InfectionsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria J.G.T. Vehreschild, University of Cologne
- Investigators
- Maria Vehreschild, MD, Principal investigator, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681068
- Sponsor's protocol ID
- MicroTrans
- Acronym
- MicroTrans
- Status last verified
- May 2017
- First submitted
- 2 Feb 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tacke D, Wisplinghoff H, Kretzschmar A, Farowski F, Koehler P, Herweg J, Cornely OA, Vehreschild MJ. First implementation of frozen, capsulized faecal microbiota transplantation for recurrent Clostridium difficile infection into clinical practice in Europe. Clin Microbiol Infect. 2015 Nov;21(11):e82-4. doi: 10.1016/j.cmi.2015.06.027. Epub 2015 Jul 8. No abstract available.
PubMed 26163107Bestfater C, Vehreschild MJGT, Stallmach A, Tuffers K, Erhardt A, Frank T, Gluck T, Goeser F, Sellge G, Solbach P, Eisenlohr H, Storr M; German Clinical Microbiome Study Group (GCMSG). Clinical effectiveness of bidirectional fecal microbiota transfer in the treatment of recurrent Clostridioides difficile infections. Dig Liver Dis. 2021 Jun;53(6):706-711. doi: 10.1016/j.dld.2021.02.022. Epub 2021 Mar 18.
PubMed 33744169Hagel S, Fischer A, Ehlermann P, Frank T, Tueffers K, Sturm A, Link A, Demir M, Siebenhaar A, Storr M, Glueck T, Siegel E, Solbach P, Goeser F, Koelbel CB, Lohse A, Luebbert C, Kandzi U, Maier M, Schuerle S, Lerch MM, Tacke D, Cornely OA, Stallmach A, Vehreschild M; German Clinical Microbiome Study Group (GCMSG). Fecal Microbiota Transplant in Patients With Recurrent Clostridium Difficile Infection. Dtsch Arztebl Int. 2016 Sep 5;113(35-36):583-9. doi: 10.3238/arztebl.2016.0583.
PubMed 27658471
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT02681068
- Acronym / sponsor ID
- MicroTrans / MicroTrans
- Conditions
- Clostridium Infections
- Keywords
- Fecal microbiota transplantation (FMT), Clostridium difficile associated diarrhea (CDAD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Feb 2016 (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 registry collects cases of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to implement a standardization of FMT in German hospitals and improve patient outcome. Therefore, a detailed description of completions of FMT are documented on our web-based survey platform www.ClinicalSurveys.net.
Detailed description
Concerning the documentation of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD), physicians from all German hospitals performing a FMT are invited to provide prospective and retrospective information on these cases. Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.
The following data items are retrospectively or prospectively documented into our database, depending on if a informed consent exists or not:
- Patient characteristics (age, gender, weight, height, underlying disease)
- Indication for FMT
- Administration of antibiotics, chemotherapy, and immunosuppression prior to FMT
- Bowel movement prior to FMT
- Screening prior to FMT
- Description concerning completion of FMT
- Basic informations of the donor
- Outcome
- Prospective long term follow up (10 days, four weeks, three months, six months, and 24 months)
The following two differences of data documentation are observed:
- Retrospective data documentation: Data of patients without an informed consent are documented strictly retrospectively after completion of the FMT. No pseudonymization of patient data is carried out so that no re-identification is possible.
- Prospective data documentation:
Data of patients with an informed consent prior to FMT are documented prospectively. A pseudonymization of patient data allows a post-FMT contact (by writing or phone) to patients with respect to the 10 days, four weeks, three months, six months,and 24 months follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent Clostridium difficile infection
Key inclusion criteria (1 listed)
- Patients with Clostridium difficile associated diarrhea
Key exclusion criteria (1 listed)
- Patients < 18 years old
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 |
|---|---|---|
| Fecal microbiota transplantation (FMT)Fecal microbiota transplantation (FMT) for patients with Clostridium difficile associated diarrhea | Other | – |
Primary outcome
Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT)
Time frame: 24 months after FMT
A 24 month follow-up allows analyses of long-term effects of FMT
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months after FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Results publication: PubMed 26163107Tacke D, Wisplinghoff H, Kretzschmar A, Farowski F, Koehler P, Herweg J, Cornely OA, Vehreschild MJ. First implementation of frozen, capsulized faecal microbiota transplantation for recurrent Clostridium difficile infection into clinical practice in Europe. Clin Microbiol Infect. 2015 Nov;21(11):e82-4. doi: 10.1016/j.cmi.2015.06.027. Epub 2015 Jul 8. No abstract available.
- Derived from this study: PubMed 33744169Bestfater C, Vehreschild MJGT, Stallmach A, Tuffers K, Erhardt A, Frank T, Gluck T, Goeser F, Sellge G, Solbach P, Eisenlohr H, Storr M; German Clinical Microbiome Study Group (GCMSG). Clinical effectiveness of bidirectional fecal microbiota transfer in the treatment of recurrent Clostridioides difficile infections. Dig Liver Dis. 2021 Jun;53(6):706-711. doi: 10.1016/j.dld.2021.02.022. Epub 2021 Mar 18.
- Derived from this study: PubMed 27658471Hagel S, Fischer A, Ehlermann P, Frank T, Tueffers K, Sturm A, Link A, Demir M, Siebenhaar A, Storr M, Glueck T, Siegel E, Solbach P, Goeser F, Koelbel CB, Lohse A, Luebbert C, Kandzi U, Maier M, Schuerle S, Lerch MM, Tacke D, Cornely OA, Stallmach A, Vehreschild M; German Clinical Microbiome Study Group (GCMSG). Fecal Microbiota Transplant in Patients With Recurrent Clostridium Difficile Infection. Dtsch Arztebl Int. 2016 Sep 5;113(35-36):583-9. doi: 10.3238/arztebl.2016.0583.
- 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. This study is not recruiting at the moment.
Maria Vehreschild, MD principal investigator
University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
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 Clostridium Infections, run by University of Cologne at 1 site in Germany.
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 4 May 2017. 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 Germany. 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 Maria Vehreschild, MD (+49 221 478 88794, maria.vehreschild@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants without another Clostridium difficile infection after fecal microbiota transplantation (FMT) (time frame: 24 months after FMT). 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 NCT02681068, which also lists 3 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 4 May 2017.