Ileal Pouchitis

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8 Ileal Pouchitis Trials Near You

Power is an online platform that helps thousands of Ileal Pouchitis patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

EXE-346 for Ileal Pouch

Grand Rapids, Michigan
This trial tests EXE-346, a mix of eight good bacteria, to help patients with IPAA who have frequent bowel movements. The treatment aims to balance the gut environment and reduce bathroom trips, improving their quality of life.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65

50 Participants Needed

This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

34 Participants Needed

Background: Ulcerative colitis (UC) and inflammatory bowel unclassified (IBDu) are inflammatory bowel diseases (IBD) involving the colon and rectum. It is a chronic disease occurring in young people with a high burden on social and professional life. Although treated medically by immunomodulatory drugs, about 15 - 20% of UC patients will need an ileal pouch-anal anastomosis (IPAA). In primary cases, this procedure is usually performed laparoscopically (further called transabdominal IPAA or tabd-IPAA). More recently even less invasive surgical techniques have emerged, using a trans-anal access, facilitating dissection of the distal rectum. Although transanal access is associated with a good postoperative outcome profile, there is very limited data on functional outcome in patients with a trans-anal ileal pouch-anal anastomosis surgery (ta-IPAA). Objective: The objective of this study is to determine if functional outcome following ta-IPAA is the same as or better than postoperative function after tabd-IPAA with UC and IBDu. Study design: The FUNCTIon trial is a non-inferiority randomized, controlled trial that will involve 3 hospitals across North-America and Europe. Patient population: All patients with UC and IBDu eligible for pelvic pouch procedure will be randomized to either ta-IPAA or tabd-IPAA. Prior to the start of the study REB will be obtained at all centres and informed consent will be obtained from all patients. The inclusion criteria for the study are: patients between 18 and 60 years old with UC or IBD unclassified (IBDu) eligible for surgery. They will need to speak either English or the primary language of the center they are treated at. The exclusion criteria for the study are: contraindication for laparoscopy, familial adenomatous polyposis (FAP), colorectal cancer, presence of primary sclerosing cholangitis (PSC), a hand-sewn ileo-anal anastomosis, immunomodulating therapy including steroids, pregnancy and lactating, urgent indication. Intervention: ta-IPAA or tabd-IPAA. Outcomes: Primary outcome is the functional outcome at one year after pelvic pouch surgery. This will be measured using the validated Colorectal Functional Outcome (COREFO) questionnaire. Secondary outcomes are functional outcome at 3 and 6 months, male and female sexual function, perioperative measures and clinical measures. Sample Size: A sample of 48 (24 per group) is required to detect a between-group non-inferiority margin of 7.05 in COREFO score with a 1-sided α of 0.05 and a power of 80%, allowing for 20% attrition. A participation rate of 50% is anticipated. Analysis: All continuous variable outcomes will be compared using analysis of covariance. Categorical variable outcomes will be analyzed using repeated measures logistic regression. Proportional outcomes will be analyzed with the chi-square or Fisher's exact test and continuous variables will be analyzed with student's t-test. Follow-up: Each participant will be followed up at 6 weeks, 3 months, 6 months and 12 months after the intervention to assess functional scores and clinical events. Perioperative events (including postoperative complications) will be assessed during the intervention hospitalization period.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60

48 Participants Needed

Mirikizumab for Pouchitis

Chapel Hill, North Carolina
The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are: Does mirikizumab reduce symptoms of pouch disorders Participants will: Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4

25 Participants Needed

Rifaximin for Pouchitis

Chapel Hill, North Carolina
Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4

16 Participants Needed

The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Early Phase 1

16 Participants Needed

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

109 Participants Needed

The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) continue to have inflammation similar to their previous disease. Only a few microbes are known to have the capability to modify primary bile acids (PBAs) made by the liver to secondary bile acids (SBAs). SBAs are some of the most common metabolites in the colon and play key roles in several diseases. In this study the investigators will investigate if ursodeoxycholic acid (UDCA) may reduce inflammatory markers and improve quality of life (as assessed by validate survey) in those subjects with active antibiotic refractory or antibiotic dependent pouchitis.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3

15 Participants Needed

Why Other Patients Applied

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

ZS
Depression PatientAge: 51

"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."

HZ
Arthritis PatientAge: 78

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31

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Frequently Asked Questions

How much do Ileal Pouchitis clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Ileal Pouchitis clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Ileal Pouchitis trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Ileal Pouchitis is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Ileal Pouchitis medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Ileal Pouchitis clinical trials?

Most recently, we added Mirikizumab for Pouchitis, Fecal Microbiota Transplant for Chronic Pouchitis and Rifaximin for Pouchitis to the Power online platform.

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