NCT02399618

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

March 21, 2015

Last Update Submit

May 24, 2016

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile InfectionFecal Microbiota TransplantationFreeze-driedAcid-resistant Capsules

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change of fecal bacteriology

    Up to 1 month post-FMT

Study Arms (1)

Capsulized freeze-dried FMT

EXPERIMENTAL

Reconstitution of normal flora with capsulized freeze-dried fecal inoculum

Drug: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota TransplantationDRUG

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

Also known as: Fecal bacteriotherapy
Capsulized freeze-dried FMT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Ning Li, MD

    Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

    STUDY DIRECTOR

Central Study Contacts

Chao Ding, MD candidate

CONTACT

+86-25-80860036dingchao19910521@126.com

Ning Li, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD candidate

Study Record Dates

First Submitted

March 21, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations

CN(1)