Back to resultsStudy to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Primary Purpose
Active Ulcerative Colitis (UC)
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRIM-DJ2727 - FROZEN
PRIM-DJ2727 - CAPSULES
Sponsored by
About this trial
This is an interventional treatment trial for Active Ulcerative Colitis (UC)
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: PRIM-DJ2727 - FROZEN
Experimental: PRIM-DJ2727 - CAPSULES
Arm Description
Outcomes
Primary Outcome Measures
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
Change in fecal microbiota diversity and genera as assessed by sequencing
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
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)
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)
Secondary Outcome Measures
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
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
Change in fecal microbiota diversity and genera as assessed by sequencing
Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
Full Information
NCT ID
NCT05786404
First Posted
March 13, 2023
Last Updated
May 23, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05786404
Brief Title
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Official Title
A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
April 15, 2026 (Anticipated)
Study Completion Date
April 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Ulcerative Colitis (UC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: PRIM-DJ2727 - FROZEN
Arm Type
Experimental
Arm Title
Experimental: PRIM-DJ2727 - CAPSULES
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRIM-DJ2727 - FROZEN
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PRIM-DJ2727 - CAPSULES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
Description
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
Title
Change in fecal microbiota diversity and genera as assessed by sequencing
Time Frame
Baseline,end of treatment (4 weeks after baseline)
Title
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
Time Frame
Baseline,end of treatment (4 weeks after baseline)
Title
Safety as assessed by the adverse events
Description
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
Title
Safety as assessed by the adverse events
Description
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
Secondary Outcome Measure Information:
Title
Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Description
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)
Title
Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Description
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)
Title
Change in fecal microbiota diversity and genera as assessed by sequencing
Time Frame
Baseline,end of treatment (4 weeks after baseline), 6 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Herbert L DuPont, MD
Phone
713 500 6687
Email
herbert.l.dupont@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Dong Jiang, Dr.PH
Phone
713 500 9371
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert L DuPont, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert L DuPont, MD
Phone
713-500-9366
Email
herbert.l.dupont@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Zhi-Dong Jiang, Dr.PH
Phone
713 500 9371
Email
zhi-dong.jiang@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
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