Clinical trial NCT02399618: Freeze-dried, Capsulized FMT for RCDI
Official title: Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile Infection
Fecal Microbiota Transplantation
Freeze-dried
Acid-resistant Capsules
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety is assessed by clinical symptoms, exam, signs (GI and systemic).
timeFrame: Up to 3 months post-FMT
measure: Efficacy
timeFrame: Up to 3 months post-FMT
Secondary outcomes:
measure: Change of fecal bacteriology
timeFrame: Up to 1 month post-FMT
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
name: Ning Li, MD
role: STUDY_DIRECTOR
References: