Freeze-dried, Capsulized FMT for RCDI

Study Overview
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Brief Summary
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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.

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

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Fecal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile Infection, Fecal Microbiota Transplantation, Freeze-dried, Acid-resistant Capsules