Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease

Inclusion Criteria:

• 18 years of age or older

• History of allogeneic hematopoietic stem cell transplant in the past 365 days

• Post-engraftment, defined by time period following three consecutive days ofsustained neutrophil engraftment with an absolute neutrophil count of at least 500cells/mm^1

• Mild to severe acute GI GvHD, at least stage 1, as measured by one of the following:

• Modified Glucksberg criteria for GI GvHD averaged over 3 consecutive days andwithout another explanation for diarrhea such as laxative use or infection. Inpatients who have already had GI biopsy, biopsy histology must be compatiblewith GVHD, although biopsy is not required

• Biopsy evidence of GI GVHD in the upper or lower GI tract

Exclusion Criteria:

• History of previous serious adverse events associated with FMT

• History of bowel perforation in the last 90 days

• History of gastrointestinal resection in the last 90 days

• History of intestinal obstruction in the last 90 days

• History of diverticulitis in the last 90 days

• History of celiac disease confirmed by serologic testing or small bowel biopsy

• History of severe dietary allergy as designated by World Allergy OrganizationSubcutaneous Immunotherapy Systemic Reaction Grading System grade 2 or more

• Subjects who are cytomegalovirus (CMV) seronegative at the time of enrollment asindicated by clinical testing unless the fecal microbiota transplant (FMT) donor isCMV seronegative with negative plasma polymerase chain reaction (PCR) assays forCMV.

• Known allergies to loperamide, sodium chloride, glycerol, theobroma oil, hide bovinegelatin, sodium lauryl sulfate, colorants FD&C, titanium dioxide, polyethyleneglycol, sodium sulfate, sodium bicarbonate, sodium phosphate, benzalkonium chloride,disodium EDTA or potassium chloride.

• Currently pregnant, planning to become pregnant or breastfeeding during the studyperiod. Women of childbearing potential (those who are not post-menopausal orpost-hysterectomy) must be negative for pregnancy per urine pregnancy test atenrollment

• Individuals with the ability to conceive children who are not willing to abstainfrom sexual activity or use an effective form of birth control during the durationof the study

• Unwilling or unable to participate in study procedures including oral intake of FMT,colonoscopy, fiber supplementation, collection of stool samples and completion studysurveys

• Cannot reasonably and safely participate in the study in the opinion of theinvestigators