Freeze-dried, Capsulized FMT for RCDI

NCT ID: NCT02399618

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capsulized freeze-dried FMT

Reconstitution of normal flora with capsulized freeze-dried fecal inoculum

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: DRUG

Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule

Interventions

Fecal Microbiota Transplantation

Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule

Intervention Type: DRUG

Other Intervention Names

Fecal bacteriotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Ding Chao

MD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ning Li, MD

Role: STUDY_DIRECTOR

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Locations

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chao Ding, MD candidate

Role: CONTACT

dingchao19910521@126.com

+86-25-80860036

Ning Li, MD

Role: CONTACT

liningrigs@vip.sina.com

+86-25-80860089

Facility Contacts

Chao Ding, MD candidate

Role: primary

dingcaho199105121@126.com

+86-25-80860036

Ning Li, MD

Role: backup

liningrigs@vip.sina.com

+86-25-80860089

Other Identifiers

Freeze-dried FMT-2015

Identifier Type: -

Identifier Source: org_study_id