Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The University of Texas Health Science Center, Houston
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Recipients
Male and female patients ≥ 18 years of age
Sexually active male and female patients of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
Female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
Required to sign an informed consent form
Deemed likely to survive for ≥ 3 months after enrolment
Diagnosis of ≥ 3 recurrent CDAD (RCDAD) bouts in outpatients or ≥ 2 bouts of CDAD in an inpatient without other explanation for diarrhea and with ≥ 2 positive fecal tests for C. difficile toxin
Referred by subjects attending physician who will provide non-transplant care for the subject and follow up at 1, 7, 14, 30 days after FMT
Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days
Anti-Clostridium difficile infection (CDI) antibiotic treatment stopped 2-4 days before the transplantation
Donors
Able to provide and sign informed consent
Able to complete and sign the donor questionnaire
Able to adhere to fecal transplantation stool collection requirements
You may not be if
Recipients
Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L
Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
Peripheral white blood cell count \> 15.0 x 109/L AND temperature \> 38.0 °C
Active gastroenteritis due to Salmonella, Shigella, E. coli 0157:H7, Yersinia or Campylobacter, and Norovirus
Presence of colostomy
Unable to tolerate human biotherapy (HBT) for any reason
Requiring systemic antibiotic therapy for more than 7 days
Actively taking Saccharomyces boulardii or other probiotic
Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
Prolonged compromised immunity due to cytotoxic chemotherapy or HIV infection
Donors
Test positive for any of variables
History of any type of active cancer or autoimmune disease
History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
History of gastrointestinal disorder, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
Receipt of any type of live vaccine within 3 months prior to stool donation
Current or previous medical or psychosocial condition
Body mass index over 30
Clareo Health | Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
