Freeze-dried, Capsulized FMT for RCDI

Phase 1

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Fecal Microbiota Transplantation

• Registration Number: NCT02399618
• Lead Sponsor: Jinling Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-21
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsulized freeze-dried FMT	Fecal Microbiota Transplantation	Reconstitution of normal flora with capsulized freeze-dried fecal inoculum

Primary Outcome Measures

Name	Time	Method
Safety is assessed by clinical symptoms, exam, signs (GI and systemic).	Up to 3 months post-FMT	Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
Efficacy	Up to 3 months post-FMT	Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China