Freeze-dried, Capsulized FMT for RCDI

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02399618

Enrollment

Registered

2015-03-26

Start date

2015-03-31

Completion date

2016-12-31

Last updated

2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile Infection, Fecal Microbiota Transplantation, Freeze-dried, Acid-resistant Capsules

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.

Interventions

DRUGFecal Microbiota Transplantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactChao Ding, MD candidate

dingchao19910521@126.com+86-25-80860036

Backup ContactNing Li, MD

liningrigs@vip.sina.com+86-25-80860089

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026