Freeze-dried, Capsulized FMT for RCDI

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.

Study Overview

• Status: Unknown
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Drug: Fecal Microbiota Transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chao Ding, MD candidate; Phone Number: +86-25-80860036; Email: dingchao19910521@126.com
• Study Contact Backup: Name: Ning Li, MD; Phone Number: +86-25-80860089; Email: liningrigs@vip.sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
      • Contact: Ning Li, MD; Phone Number: +86-25-80860089; Email: liningrigs@vip.sina.com
      • Contact: Chao Ding, MD candidate; Phone Number: +86-25-80860036; Email: dingcaho199105121@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsulized freeze-dried FMT; Reconstitution of normal flora with capsulized freeze-dried fecal inoculum	Drug: Fecal Microbiota Transplantation; Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule; Other Names: Fecal bacteriotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Efficacy	Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.	Up to 3 months post-FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of fecal bacteriology	Fecal microbiology is characterized by 16S rRNA gene-based analysis.	Up to 1 month post-FMT

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Director: Ning Li, MD, Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 21, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Clostridium difficile Infection; Freeze-dried; Acid-resistant Capsules
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Clostridium Infections
• Other Study ID Numbers: Freeze-dried FMT-2015