Back to resultsFreeze-dried, Capsulized FMT for RCDI
Primary Purpose
Clostridium Difficile Infection
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium difficile Infection, Fecal Microbiota Transplantation, Freeze-dried, Acid-resistant Capsules
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capsulized freeze-dried FMT
Arm Description
Reconstitution of normal flora with capsulized freeze-dried fecal inoculum
Outcomes
Primary Outcome Measures
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Efficacy
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.
Secondary Outcome Measures
Change of fecal bacteriology
Fecal microbiology is characterized by 16S rRNA gene-based analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02399618
Brief Title
Freeze-dried, Capsulized FMT for RCDI
Official Title
Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile Infection, Fecal Microbiota Transplantation, Freeze-dried, Acid-resistant Capsules
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capsulized freeze-dried FMT
Arm Type
Experimental
Arm Description
Reconstitution of normal flora with capsulized freeze-dried fecal inoculum
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
Fecal bacteriotherapy
Intervention Description
Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule
Primary Outcome Measure Information:
Title
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Description
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Time Frame
Up to 3 months post-FMT
Title
Efficacy
Description
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.
Time Frame
Up to 3 months post-FMT
Secondary Outcome Measure Information:
Title
Change of fecal bacteriology
Description
Fecal microbiology is characterized by 16S rRNA gene-based analysis.
Time Frame
Up to 1 month post-FMT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Ding, MD candidate
Phone
+86-25-80860036
Email
dingchao19910521@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, MD
Phone
+86-25-80860089
Email
liningrigs@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Organizational Affiliation
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Ding, MD candidate
Phone
+86-25-80860036
Email
dingcaho199105121@126.com
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
+86-25-80860089
Email
liningrigs@vip.sina.com
12. IPD Sharing Statement
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Freeze-dried, Capsulized FMT for RCDI
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