Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

NCT05786404 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HSC-MS-23-0016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (5)

• 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 (4)

• Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score

  baseline, week 5, early termination(if applicable)

• Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)

  baseline, week 5, early termination(if applicable)

• Change in fecal microbiota diversity and genera as assessed by sequencing

  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

  Baseline,end of treatment (4 weeks after baseline), 6 months follow up

Study Arms (2)

Experimental: PRIM-DJ2727 - FROZEN

EXPERIMENTAL

Drug: PRIM-DJ2727 - FROZEN

Experimental: PRIM-DJ2727 - CAPSULES

EXPERIMENTAL

Drug: PRIM-DJ2727 - CAPSULES

Interventions

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

Experimental: PRIM-DJ2727 - FROZEN

PRIM-DJ2727 - CAPSULES DRUG

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.

Experimental: PRIM-DJ2727 - CAPSULES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Herbert L DuPont, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herbert L DuPont, MD

CONTACT

713 500 6687; herbert.l.dupont@uth.tmc.edu

Zhi-Dong Jiang, Dr.PH

CONTACT

713 500 9371

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)