Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Leland Metheny
Age
19–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
One of the following diagnosis:
High risk aGVHD (either biopsy proven or clinical diagnosed) (see Appendix B \& C) as defined by either:
* Lower gastrointestinal (GI) stage 3+
* Hyper-acute GVHD as defined by aGVHD of the GI tract within the first 14 days of transplant AND
* Subjects with treatment-naive acute GVHD as defined as those who have not received previous systemic treatment for acute GVHD, except for a maximum of 7 days of no less than 1 mg/kg/day of methyl-prednisolone (or equivalent dose of prednisone).
OR:
Steroid refractory aGVHD of the GI tract (either biopsy proven or clinical diagnosed) as defined by:
* no response to steroid treatment (minimum daily dose: 2 mg/kg methyl-prednisolone or equivalent) lasting at least 7 days, or
* progression of at least one grade within the first 72 h of treatment
ECOG Performance status \< 3
Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source.
Patients who are able stop prophylactic antibiotics during the treatment period
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
You may not be if
Active malignancy
Patients with any concurrent uncontrolled clinically significant medical condition including active infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
Pregnant or breastfeeding women
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
Patients with any severe gastrointestinal condition other than GI-GVHD.
Inability (e.g. dysphagia) to or unwilling to swallow capsules
Active gastrointestinal infection at time of enrollment
Known or suspected toxic megacolon and/or known small bowel ileus
Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy
History of total colectomy or bariatric surgery
Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy
Unable or unwilling to comply with protocol requirements
Expected life expectancy \< 6 months
Patients who have CMV \>2,000 copies/mL of whole blood or EBV \>2,000 copies/mL of whole blood.
Clareo Health | Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD
