Clostridium Difficile InfectionPhase 1NCT02399618
Freeze-dried, Capsulized FMT for RCDI
A Phase 1 study testing Fecal Microbiota Transplantation in people with Clostridium Difficile Infection, run by Jinling Hospital, China at 1 site in China.
Trial summary
Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with refractory, recurrent or relapsing C. difficile infection (RCDI), as defined in guidelines as a relapse of CDI after having at least 3 episodes of mild to moderate CDI and failure of a 6- to 8-week taper with vancomycin with or without an alternative antibiotic or at least 2 episodes of severe CDI resulting in hospitalization and associated with significant morbidity;
- Willingness to accept risk of healthy unrelated donor stool.
Who cannot join
- Delayed gastric emptying syndrome;
- Known chronic aspiration;
- Swallowing dysfunction or oral-motor dyscoordination;
- Pregnant or breast-feeding women;
- Usage of probiotics, prebiotics or synbiotics within the last month;
- Smoking or alcohol use within the last month;
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- Patients with an exacerbation of condition not because of CDI;
- Patients on major immunosuppressive agents or with any other cause of severe immunodeficiency;
- Patients with a history of significant allergy because of diet;
- Patients on any agents affecting fecal bacteriology because of comorbidities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Chao Ding, MD candidate, +86-25-80860036, dingcaho199105121@126.com
Ning Li, MD, +86-25-80860089, liningrigs@vip.sina.com
About this study
Official title: Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fecal Microbiota Transplantation
- Keywords
- Clostridium difficile Infection, Fecal Microbiota Transplantation, Freeze-dried, Acid-resistant Capsules
- 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 TransplantationDrug
Also called Fecal bacteriotherapy
Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule
| Study group | Role | What they receive |
|---|---|---|
| Capsulized freeze-dried FMT | Experimental | Reconstitution of normal flora with capsulized freeze-dried fecal inoculum Receives: Drug: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Measured: Up to 3 months post-FMT
Efficacy
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.
Measured: Up to 3 months post-FMT
Secondary outcomes (1)
Change of fecal bacteriology
Fecal microbiology is characterized by 16S rRNA gene-based analysis.
Measured: Up to 1 month post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Chao, Jinling Hospital, China
- Investigators
- Ning Li, MD, Study director, Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399618
- Sponsor's protocol ID
- Freeze-dried FMT-2015
- Status last verified
- May 2016
- First submitted
- 21 Mar 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02399618
- Acronym / sponsor ID
- Freeze-dried FMT-2015
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile Infection, Fecal Microbiota Transplantation, Freeze-dried, Acid-resistant Capsules
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Mar 2015 (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.
Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capsulized freeze-dried FMT | Experimental | Drug: Fecal Microbiota TransplantationReconstitution of normal flora with capsulized freeze-dried fecal inoculum |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with refractory, recurrent or relapsing C. difficile infection (RCDI), as defined in guidelines as a relapse of CDI after having at least 3 episodes of mild to moderate CDI and failure of a 6- to 8-week taper with vancomycin with or without an alternative antibiotic or at least 2 episodes of severe CDI resulting in hospitalization and associated with significant morbidity;
- Willingness to accept risk of healthy unrelated donor stool.
Key exclusion criteria (10 listed)
- Delayed gastric emptying syndrome;
- Known chronic aspiration;
- Swallowing dysfunction or oral-motor dyscoordination;
- Pregnant or breast-feeding women;
- Usage of probiotics, prebiotics or synbiotics within the last month;
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 TransplantationAlso: Fecal bacteriotherapyFecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule | Drug | Capsulized freeze-dried FMT |
Primary outcome
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Time frame: Up to 3 months post-FMT
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Efficacy
Time frame: Up to 3 months post-FMT
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.
1 secondary outcome
Change of fecal bacteriology
Time frame: Up to 1 month post-FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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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.
Ning Li, MD study director
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplantation in people with Clostridium Difficile Infection, run by Jinling Hospital, China 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 2 inclusion and 10 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 25 May 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chao Ding, MD candidate (+86-25-80860036, dingchao19910521@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety is assessed by clinical symptoms, exam, signs (GI and systemic). (time frame: Up to 3 months post-FMT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2016.