Clostridium Difficile Clinical Trial
Official title:
A Pilot Study Examining the Safety and Efficacy of Early Fecal Transplant in Patients Infected With Clostridium Difficile at High Risk of Relapse
Verified date | January 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clostridium difficile infection (CDI) has increased worldwide in both frequency and severity.
It is the leading cause of hospital acquired infection in developed countries and has been
associated with at least 14,000 deaths per year in the United States. With 3 million cases/
year, the annual cost for treating the infection is exceeding 3 billion dollars. It can also
have a profound negative impact on quality of life.
The investigators believe that patients who are at high risk of relapse after a first CDI
episode would benefit from early fecal microbial transplant (FMT). The proposed study will
produce preliminary data regarding safety and efficacy and potential for cost effectiveness
for the use of early fecal transplant in those patients with their first episode of
non-refractory CDI who are predicted to have a high rate of recurrence based on previously
published risk factors. The investigators will be better prepared to test the efficacy of
this approach in a future multicenter clinical trial in a randomized controlled fashion.
The purpose of this study is to compare the effectiveness and safety of early fecal
transplant using donor stool from a healthy person in a group of patients who are diagnosed
with their first episode of Clostridium difficile infection and are predicted to have a high
chance of the infection returning against a similar group of patients who receive current
standard of care for treatment of C.difficile.
The investigators hypothesize:
- that clinical remission rates at 12 weeks as noted by absence of clinical symptoms
and/or negative C.difficile stool polymerase chain reaction (PCR) will be greater in the
experimental arm compared to the control arm
- that patients in the experimental group will have a low microbial diversity prior to FMT
but will exhibit a high microbial diversity after the FMT that resembles the respective
donor
- that the microbial diversity will be diminished in both groups at the time of
enrollment, but the experimental group will exhibit a higher microbial diversity
compared to the control population at 12 weeks
- that patients in both groups will exhibit poor quality of life at the time of
enrollment, however, the experimental group will demonstrate higher quality of life
compared to the control group at follow up after completion of treatment
- that costs incurred by the experimental group will be less than the control group
Status | Completed |
Enrollment | 13 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for the study: - First or second episode of CDI responding to therapy - Must have 2 or more of the following criteria: 1. Age >65 2. Severe underlying disease (measured by Horn index score of 3 or 4) 3. Additional non-C.difficile antibiotic exposure during CDI episode 4. Use of antacids 5. Previous episode of CDI - Willingness to accept a fecal product made using unrelated donor stool and to comply with study protocol requirements - Able to give informed consent - Chronic infection with HIV, HBV, HCV is permitted unless the viral infection compromises the ability of the patient to safely participate in the study. Patients with a CD4 count <200 and/ or AIDS defining illness or decompensated cirrhosis will not be eligible for the study. - Life expectancy >4 months Exclusion Criteria: - Any of the following: acute leukemia, history of allogenic or recent (within 6 months) autologous bone marrow transplant, or use of cytotoxic chemotherapy within 2 months - ANC <1000/mm^3 - History of inflammatory bowel disease - History of total colectomy - Pregnant or nursing mothers - History of significant food allergy to foods not excluded from the donor diet - Patient has any other condition that, in the opinion of the Investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the results of the study - Patients who are aged 80 years or greater - Patients who are incarcerated - Patient with cognitive impairment or severe neuropsychiatric co morbidities who are incapable of giving consent - Inherited/primary immune disorders - Patients who are unwilling or unable to undergo sigmoidoscopy - Unable to comply with protocol requirements - Patients with untreated, in-situ colorectal cancer |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Remission Rates | Clinical remission rate is defined as the number of participants with an absence of clinical symptoms and/or negative C.difficile stool PCR. | Post-Intervention (Week 12) | |
Primary | Number of Participants That Experience Serious Adverse Events | A serious adverse event is any adverse experience that results in any of the following outcomes: Death; Life-threatening experience (adverse event is considered "life-threatening" if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability or incapacity; Is a congenital anomaly or birth defect; Is considered to be an important medical event (that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the definition above). |
Post-Intervention (Month 6) | |
Primary | Change in the Shannon Diversity Index | The Shannon Diversity Index is a quantitative measure that reflects how many different types (such as species) there are in a dataset (a community). 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota were analyzed for both groups using the Shannon Diversity index (H). The greater the index, the more diverse a species. | Baseline, Post-Intervention (Week 12) | |
Secondary | Mean Short Form - 36 (SF-36) Score | SF-36: consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Post-Intervention (Week 12) | |
Secondary | Mean Hospital Anxiety And Depression Scale (HADS) Score | The HADS is a fourteen item scale and each item on the questionnaire is scored from 0-3, from 0 = best and 3 = worst. A score can range between 0 and 21 for either anxiety or depression. Higher scores represent greater depressive/anxious symptoms. | Post-Intervention (Week 12) | |
Secondary | Mean Cost of Treatment | Total cost was calculated as a summation of costs of medications, procedures, and fecal transplant used to treat C.difficile for each individual patient. A mean was calculated for both groups. | Post-Intervention (Month 6) |
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