Fecal Microbiota Transplant for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Antibiotics, Immunosuppressants, Chemotherapy, others
Disqualifiers: Severe UC, Active cancer, HIV, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing two ways to give healthy gut bacteria to people with active Ulcerative Colitis (UC). One method uses an enema, and the other uses pills. The goal is to see if these treatments are safe and effective by checking changes in gut bacteria and symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken systemic antibiotics within 14 days before the treatment starts or if you are on high doses of certain immune-suppressing drugs like prednisone.
What data supports the effectiveness of this treatment for ulcerative colitis?
Research shows that fecal microbiota transplantation (FMT) can help patients with ulcerative colitis (UC) who haven't responded to other treatments. Studies suggest that FMT can improve symptoms and help maintain long-term remission in UC by introducing beneficial bacteria into the gut.
12345Is fecal microbiota transplantation (FMT) safe for humans?
Fecal microbiota transplantation (FMT) is considered safe for treating recurrent Clostridium difficile infections, with established methods for donor screening and processing. However, its safety for other conditions like ulcerative colitis is still being studied, and more data is needed before it can be recommended for routine use in these cases.
14678How is fecal microbiota transplantation (FMT) different from other treatments for ulcerative colitis?
FMT is unique because it involves transferring healthy bacteria from a donor's stool to a patient's gut to restore a balanced microbiome, which is different from traditional treatments that often focus on reducing inflammation with drugs.
124910Eligibility Criteria
This trial is for adults with active Ulcerative Colitis (UC) who are not pregnant, breastfeeding, or planning pregnancy. They must have a Partial Mayo score ≥ 3 and agree to use birth control. Excluded are those with severe UC, recent antibiotics use, certain infections like HIV/Hepatitis B/C, past FMT or recurrent C. difficile infection within 6 months, compromised immune systems or significant uncontrolled diseases.Inclusion Criteria
I agree to use effective birth control during the study.
I am not pregnant, as confirmed by a negative pregnancy test.
Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls
+2 more
Exclusion Criteria
I have a history of active gastrointestinal conditions.
History of use of an investigational drug within 90 days prior to the screening visit
I cannot take medicine as an enema or swallow many pills.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Fecal Microbiota Transplantation (FMT) via retention enema or oral capsules
5 weeks
Weekly visits for treatment administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Regular follow-up visits
Participant Groups
The study tests the safety and effectiveness of fecal microbiota transplantation (FMT) in treating UC using two methods: frozen FMT via enema and lyophilized powder in capsules. It also examines changes in gut microbiome diversity after treatment.
2Treatment groups
Experimental Treatment
Group I: Experimental: PRIM-DJ2727 - FROZENExperimental Treatment1 Intervention
Group II: Experimental: PRIM-DJ2727 - CAPSULESExperimental Treatment1 Intervention
PRIM-DJ2727 - CAPSULES is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation (FMT) for:
- Recurrent Clostridioides difficile infection
🇪🇺 Approved in European Union as Fecal Microbiota Transplantation (FMT) for:
- Recurrent Clostridioides difficile infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. [2022]The strategy of using fecal microbiota transplantation (FMT) for refractory ulcerative colitis (UC) remains unclear if single FMT failed to induce remission. This study aimed to evaluate the efficacy and safety of a designed step-up FMT strategy for the steroid-dependent UC.
Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. [2018]Fecal microbial transplantation (FMT) provides to replace beneficial bacteria with more favorable microbiomes in recipient with dysbiosis. The aim of the present study was to prospectively investigate the efficacy of FMT by assessing the clinical and endoscopic response in patients with ulcerative colitis (UC) who had failed anti-inflammatory and immunosuppressive therapy.
Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. [2022]Fecal microbiota transplantation (FMT) is a promising new strategy in the treatment of Inflammatory Bowel Disease, but long-term delivery systems are lacking. This randomized study was designed as a safety and feasibility study of long-term FMT in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT).
[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. [2022]To explore the procedure, effectiveness and safety of fecal microbiota transplantation (FMT) in patients with ulcerative colitis (UC).
Re-Evaluating the Evidence for Faecal Microbiota Transplantation 'Super-Donors' in Inflammatory Bowel Disease. [2021]Faecal microbiota transplantation [FMT] is a recommended treatment for recurrent Clostridioides difficile infection, and there is promise that FMT may be effective for conditions such as inflammatory bowel disease [IBD]. Previous FMT clinical trials have considered the possibility of a 'donor effect', that is, that FMT material from different donors has different clinical efficacies.
[Faecal microbiota transplantation for the treatment of bowel disease]. [2019]Faecal microbiota transplantation (FMT) is the transferral of faeces from a healthy donor to a patient with a disease linked to disturbances in the gut microbiota. The treatment has been implemented at several hospitals in Denmark, and banks with frozen donor stool material have been established. The effect of FMT for recurrent Clostridium difficile infection is well-documented. FMT cannot be recommended for routine clinical use for inflammatory bowel disease and irritable bowel syndrome because of lack of data from clinical trials.
Endoscopic peroral jejunal fecal microbiota transplantation. [2017]Fecal microbiota transplantation (FMT) is a valuable treatment modality for recurrent Clostridium difficile (C. difficile) colitis. Multiple questions including the best delivery route and volume remain unanswered. Here, we report a case series of high-volume FMT using endoscopic jejunal application route.
Faecal microbiota transplantation: establishment of a clinical application framework. [2022]Faecal microbiota transplantation (FMT) is currently being established as a second-line treatment for recurrent Clostridium difficile infection. FMT is further being considered for other infectious and inflammatory conditions. Safe and reproducible methods for donor screening, laboratory processing and clinical application of FMT are warranted.
Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. [2022]Fecal microbiota transplantation (FMT) is an investigational treatment for diseases thought to involve alterations in the intestinal microbiota including ulcerative colitis (UC). Case reports have described therapeutic benefit of FMT in patients with UC, possibly due to changes in the microbiota. We measured the degree to which the transplanted microbiota engraft following FMT in patients with UC using a donor similarity index (DSI).
Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. [2022]Faecal microbiota transplantation (FMT) is emerging as a novel therapy for ulcerative colitis (UC). Interpretation of efficacy of FMT for UC is complicated by differences among studies in blinding, FMT administration procedures, intensity of therapy and donor stool processing methods.