Study to Evaluate the Fecal Microbiota Transplantation (F... | NCT05786404

NCT05786404

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Experimental: PRIM-DJ2727 - FROZEN	Experimental		Drug: PRIM-DJ2727 - FROZEN
Experimental: PRIM-DJ2727 - CAPSULES	Experimental		Drug: PRIM-DJ2727 - CAPSULES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRIM-DJ2727 - FROZEN	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease 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	week 5
Change in fecal microbiota diversity and genera as assessed by sequencing		Baseline,end of treatment (4 weeks after baseline)
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test		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)	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)	6 months after last dose

Secondary Outcomes

Measure	Description	Time Frame
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	baseline, week 5, early termination(if applicable)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore >1)
Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
Subject has an attending physician who will provide the non-FMT care.

Exclusion Criteria:

Subjects with sever UC (Mayo score of >7)
Unable to take retention enema or multiple capsules orally.
Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
History of recurrent Clostridium difficile infection or FMT in the past 6-months.
History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.
Known history of bile acid diarrhea
Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone >20 mg a day or prednisone-equivalent)
History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
History of use of an investigational drug within 90 days prior to the screening visit.
History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
Life expectancy of < 1 year.
In the opinion of investigator, subject for any reason, should be excluded from the study.
Absolute neutrophil count (ANC) < 500IU/mL

Name	Role	Phone	Extension	Email
Herbert L DuPont, MD	Contact	713 500 6687		herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, Dr.PH	Contact	713 500 9371