Freeze-dried, Capsulized FMT for RCDI

Clostridium Difficile Infection Clinical Trial

Official title:

Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02399618
• Other study ID #: Freeze-dried FMT-2015
• Status: Recruiting
• Phase: Phase 1
• First received: March 21, 2015
• Last updated: May 24, 2016
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Jinling Hospital, China
• Contact: Chao Ding, MD candidate
• Phone: +86-25-80860036
• Email: dingchao19910521[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Infection

Intervention

Drug:
• Fecal Microbiota Transplantation
Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety is assessed by clinical symptoms, exam, signs (GI and systemic).	Safety is assessed by clinical symptoms, exam, signs (GI and systemic).	Up to 3 months post-FMT	Yes
Primary	Efficacy	Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.	Up to 3 months post-FMT	No
Secondary	Change of fecal bacteriology	Fecal microbiology is characterized by 16S rRNA gene-based analysis.	Up to 1 month post-FMT	No