The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients with active UC will receive induction dose of 100 grams of stool via frozen retention enema, Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-FROZEN administered in clinic. This consists of microbiota suspension from well-screened donors. Twice filtered fecal microbiota product diluted in saline to 500 mL containing 100g of study drug will be administered as frozen enema induction dose
Patients with active UC will receive induction dose of 100 grams of stool in orally administered enteric-coated capsules Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-CAPSULES.These capsules consists of microbiota from well-screened donors. The induction dose of enteric-coated capsules will be derived from 100 grams stool.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGDisease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome
Time frame: week 5
Change in fecal microbiota diversity and genera as assessed by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline)
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
Time frame: Baseline,end of treatment (4 weeks after baseline)
Safety as assessed by the adverse events
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Time frame: 3 months after last dose
Safety as assessed by the adverse events
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Time frame: 6 months after last dose
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Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
This is a 10 item questionnaire and each is scored from 1(all of the time) to 7 (none of the time) for a maximum score of 70 a higher number indicating better quality of life
Time frame: baseline, week 5, early termination(if applicable)
Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
This is a fourteen-item questionnaire to assess anxiety and depression. Seven items are related to anxiety symptoms and seven to depressive symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, a higher number indicating worse outcome
Time frame: baseline, week 5, early termination(if applicable)
Change in fecal microbiota diversity and genera as assessed by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline), 6 months
Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline), 6 months follow up