Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection

NCT02686645 | Unknown Phase 2

• 1 other identifier: NSHA REB File #: 1020563
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of fecal microbiota therapy (FMT) in the investigators population.

Conditions

Clostridium Difficile Infection

Keywords

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Resolution of CDI

  Resolution of CDI will be defined as \< 3 bowel movements per day for 7 consecutive days or stool negative for Clostridium difficile (CD) on 2 consecutive stool sample at least 1 day apart within 30 days of the treatment.

  30 days

Secondary Outcomes (5)

• Success of treatment

  3 months

• Adverse effects

  6 months

• Quality of life

  day 0, 3 months and 6 months

• Recipient Satisfaction

  1week, 3 months and 6 months

• Donor Satisfaction

  1 week

Study Arms (1)

Fecal Microbiota Therapy

EXPERIMENTAL

Vancomycin 125 mg po qid for 7 days or metronidazole 500 mg po tid for 7 days pre-treatment. Loperamide 4 mg po after morning prep and 2 mg post treatment. The route of administration fecal microbiota will be by retention enema via a rectal tube.

Biological: Fecal Microbiota; Drug: vancomycin; Drug: Loperamide; Drug: metronidazole

Interventions

Fecal Microbiota BIOLOGICAL

The fecal microbiota will be by retention enema administered through a rectal tube.

Fecal Microbiota Therapy

vancomycin DRUG

All subjects will be pre-treated with vancomycin 125 mg po qid X 7 days prior to the fecal microbiota.

Fecal Microbiota Therapy

Loperamide DRUG

The subject will take 4 mg of loperamide after the morning bowel prep (approximately 1 hour prior to the procedure) and 2 mg again after the procedure.

Fecal Microbiota Therapy

metronidazole DRUG

If unable to tolerate vancomycin, then it will be substituted with metronidazole 500 mg po tid X 7 days prior to the fecal microbiota.

Fecal Microbiota Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥ 18 yrs of age.
• Recurrent CDI despite two courses of standard treatment (ie. 10 days of oral vancomycin or metronidazole) and a 6 week taper of oral vancomycin.
• Laboratory confirmation of CDI by enzyme immunoassay (EIA), cytotoxicity assay and/or polymerase chain reaction (PCR).

You may not qualify if:

• Severely immunosuppressed patients will not be enrolled. This is defined as \>20 mg prednisone/d for \>1 month, recent transplant patients (haematological \<2yrs and solid organ \< 6 months), transplant with active graft versus host disease, HIV (with CD4\<200), immunosuppressive antibody treatment (eg. tumour necrosis factor inhibitor, rituximab), other high dose long term systemic immunosuppression) and severe congenital immunodeficiency.
• Age \<18 years old.
• Pregnancy.
• Patient expected to expire in \< 30d.
• Current hospital admission for an indication other than CDI or need for vasopressor medication.

Sponsors & Collaborators

• Queen Elizabeth II Health Sciences Centre: lead

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation; Vancomycin; Loperamide; Metronidazole

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Ian R Davis, MD,FRCPC

  Dalhousie University, Department of Medicine, Division Infectious Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian R Davis, MD,FRCPC

CONTACT

902 473 8477; ian.davis@nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Medicine, Dalhousie University

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 19, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share