Fecal Microbiota Transplant

NCT04090346 | Completed Phase 4 FDA Drug

• 1 other identifier: 010.GID.2018.A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium difficile infection (CDI). This procedure is predicted to reduce the cost both financially and physically for the CDI patient and facility.

Conditions

Clostridium Difficile Infection

Keywords

CDiff; Fecal Microbiota Transplant; Infection Control; Antibiotic Stewardship

Outcome Measures

Primary Outcomes (5)

• treatment date

  date of treatment

  eight weeks following transplant.

• material volume

  volume of material

  eight weeks following transplant.

• severity and type of CDI

  severity and type of CDI

  eight weeks following transplant.

• serious adverse reactions

  serious adverse reactions

  eight weeks following transplant.

• repeat transplant, colectomy and antibiotics

  patients who require additional treatment

  eight weeks following transplant.

Study Arms (1)

Clostridium difficile infection

EXPERIMENTAL

Clostridium difficile infection (CDI) is due to a toxin-producing bacteria that causes a more severe form of antibiotic associated diarrhea. The disease ranges from mild diarrhea to severe colon inflammation that can even be fatal.

Drug: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant DRUG

Fecal Microbiota Transplant (FMT) is a procedure to replace beneficial bacteria which has been killed or suppressed in the colon.

Also known as: FMT

Clostridium difficile infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks.
• Metronidazole
• Vancomycin
• At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year
• Severe C Diff infection requiring hospitalization and non- responsive to maximal medication therapy

You may not qualify if:

• advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
• cirrhosis of the liver
• recent bone marrow transplants
• medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk)
• pregnancy
• Toxic megacolon or ileus present

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Mansfield Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Muhammad Memon, MD

  Methodist Mansfield Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: September 16, 2019
• Study Start: June 5, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: March 24, 2026

Record last verified: 2021-11

Locations

US (1)