Fecal Microbiota Transplant

010.GID.2018.A

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.

2018-06-05

2022-03-30

2022-03-30

Completed

Early phase I

24

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2024-03-28