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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Fecal Microbiota Transplantation (FMT) for people with active Ulcerative Colitis (UC), a condition that causes inflammation in the intestines. The researchers want to see how safe and effective two different forms of FMT are: one delivered as a frozen enema and the other as powdered capsules that can be swallowed. They will also look at how these treatments change the bacteria in the gut and whether they help improve UC symptoms.

To participate in this trial, you need to have a diagnosis of active UC and be willing to use effective birth control if you're of childbearing age. You should also be able to attend all study visits and follow the study’s guidelines. However, some people can't join, like those with severe UC, pregnant or breastfeeding women, and those with certain other health conditions. If you take part, you can expect to receive either the enema or capsules and will be monitored throughout the study to assess your health and the treatment’s effects.

Gender

ALL

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