Status:
WITHDRAWN
Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Acute Graft Versus Host Disease
Gastrointestinal Tract Acute Graft Versus Host Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects of using an investigational procedure (fecal microbiota transplantation \[FMT\]) in treating patients with severe acute gut graft-versus-host-disease. The p...
Detailed Description
PRIMARY OBJECTIVES: I. For safety evaluation, episodes of microbial bloodstream infection attributed to fecal microbiota transplantation (FMT) within the first 7 days after start of each FMT administ...
Eligibility Criteria
Inclusion
- Subjects who received an allogenic hematopoietic stem cell transplantation (HSCT)
- Acute GvHD defined as experiencing GvHD symptoms starting prior to day +100 after HSCT
- Gut GvHD defined as subjects experiencing GvHD symptoms consistent with stage 3 or stage 4 by Center for International Blood and Marrow Transplant Research (CIBMTR) staging:
- Stage 3 acute gut GvHD subjects having 1500-1999 mL stool per day
- Stage 4 subjects having greater than 2 liters of stool per day and/or severe abdominal cramping, bleeding or ileus
- Steroid-refractory acute gut GVHD defined as progression of symptoms after 3 days of systemic steroids (\> 1 mg/kg/day methylprednisolone) or steroid-resistant acute gut GvHD defined stable symptoms after 5 days of systemic steroids (\> 1 mg/kg/day methylprednisolone)
- Able to swallow capsules without aspiration or dysphagia
- Ability to understand the written informed consent and the willingness to sign the consent and accept the risk of receiving unrelated donor stool
Exclusion
- Absolute neutrophil count \< 500 cells/uL
- Presence of recurrent Clostridium difficile infection
- Presence of ileus or toxic megacolon
- History of multi-drug resistant stool pathogen
- History of inflammatory bowel disease (i.e Crohn's disease or ulcerative colitis)
- Uncontrolled and active systemic infection from bacteria, virus or fungus
- Human immunodeficiency virus (HIV)-positive subjects
- Quantifiable cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) evaluated by polymerase chain reaction (PCR) after hematopoietic stem cell transplantation (HSCT) and after neutrophil engraftment defined as absolute neutrophil count (ANC) \> 500 cells/uL
- Hemodynamically unstable
- Active gastrointestinal bleed
- Pregnant and/or breastfeeding women
- Dysphagia due to oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, amyotrophic lateral sclerosis \[ALS\]) or subject shows evidence of dysphagia when the 'safety test' capsule is administered
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Subjects with a history of significant allergy to foods
- Subjects with allergies to sodium chloride, glycerol, theobroma oil, hide bovine gelatin, sodium lauryl sulfate, colorants Federal Food, Drug, and Cosmetic Act (FD\&C), or titanium dioxide, all ingredients generally recognized as safe (GRAS)
- History of previous gastrointestinal surgery
- Subjects who are receiving other investigational agents for treatment of gut GvHD
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04280471
Start Date
September 1 2023
End Date
December 1 2025
Last Update
September 22 2023
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095