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Pouchitis clinical trials

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NCT ID: NCT05578313 Recruiting - Healthy Clinical Trials

Inflammatory Bowel Diseases (IBD) Cannabis Registry

IBD
Start date: July 10, 2019
Phase:
Study type: Observational

The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pain, diarrhea, and rectal bleeding during active disease. Medical therapy reduces intestinal inflammation and ameliorates symptoms. Medical cannabis has recently been added to the arsenal of symptom-reducing measures in IBD. Though the efficacy of THC and CBD have been established as the two most dominant ingredients of cannabis, the rest of the plant phytochemicals are unknown, and effects on patients are not yet determined.

NCT ID: NCT04998084 Recruiting - Ulcerative Colitis Clinical Trials

Advanced Therapy Registry of IBD Patients

Start date: February 28, 2019
Phase:
Study type: Observational

The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.

NCT ID: NCT04979832 Recruiting - Pouchitis Clinical Trials

GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery

Start date: September 6, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will examine whether the application of GM-CSF, fosfomycin and metronidazole locally in the pouch is safe and effective in the treatment of pouchitis for patients with ulcerative colitis, and whether treatment changes the microbiome of the pouch.

NCT ID: NCT04912999 Recruiting - Ulcerative Colitis Clinical Trials

Inflammatory Bowel Diseases Remission Registry

Start date: August 1, 2019
Phase:
Study type: Observational [Patient Registry]

The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pain, diarrhea, and rectal bleeding during active disease. Medical therapy reduces intestinal inflammation and ameliorates symptoms. Clinical remission is defined when symptoms are resolved. In these periods, patients are able to perform daily activities more freely and lead a normal lifestyle. Biochemical remission (normalization of CRP and fecal Calprotectin) and endoscopic remission (no visual signs of inflammation of the mucosa in endoscopy) are the goals of IBD treatment. Unfortunately, 30-40% of patients will relapse during 6 months from achieving remission. Risk factors for disease exacerbation are still unknown, and no guidelines exist as to the prevention of relapse and maintenance of remission in IBD patients. In addition to the above, sleep disturbances and disturbances in the circadian rhythm can be a potential cause of flare-up. Sleep disorders cause changes in immune function, which later affect the course of the disease in IBD. This back affects the sleep pattern, so that a cycle is created, which may perpetuate the inflammation. The interactions between sleep and inflammation are complex. An effective immune system affects sleep, and sleep disorders affect the functioning of the immune system. Furthermore, changes in the biological clock and sleep deprivation have been directly shown to worsen ulcerative colitis in laboratory animals. In people with sleep disorders, high levels of inflammation were found. However, it is difficult to dissect the cause and effect for these associations, given their complex interactions. Therefore we are planning to conduct a prospective study to assess variety of factors that might be associated with the activity of IBD.

NCT ID: NCT04327219 Recruiting - Pouchitis Clinical Trials

Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for patients with ulcerative colitis (UC) who require surgery. Inflammation of the ileal pouch (pouchitis) occurs in up to 60% of pouch patients. Although, pouchitis patients are former UC patients, the disease occurs in the small intestine, similarly to Crohn's disease (CD). Further, the disease can be clinically similar to CD, involving the proximal gastro-intestinal tract and causing strictures, fistula, or perianal disease. The Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. The diet also provides dietary components that may favor species (especially SCFA producers) which appear to be deficient in CD. The investigator therefore aims to examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in a cohort of adults suffering from active pouchitis.

NCT ID: NCT04089345 Recruiting - Pouchitis Clinical Trials

Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

SOCRATES
Start date: June 11, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.

NCT ID: NCT04082559 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease

Bio-MDT
Start date: June 11, 2019
Phase: N/A
Study type: Interventional

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient's quality of life. Despite important advances in research, the pathogenesis of IBD remains obscure, the incidence-rising, the condition - incurable, and drugs have a modest effect. The common denominator may be environmental factors, specifically diet and the microbiome, which remain a fundamental unmet need in IBD care as high quality randomized trials and mechanistic research are limited. Up to a quarter of patients with UC may undergo complete large bowel resection due to disease complications. In order to preserve bowel continuity, this surgery includes a restorative part with creation of a reservoir ("pouch") from normal small bowel instead of the resected rectum. The majority of these patients develop small intestinal inflammation in the previously normal small bowel creating the pouch ("pouchitis"). Based on our results from previous studies, we hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch. Aims: 1. Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation. 2. Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery. 3. Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery. 4. Identify predictors for response to specific antibiotic and dietary interventions.

NCT ID: NCT03724175 Recruiting - Ulcerative Colitis Clinical Trials

The Role of Secondary Bile Acids in Intestinal Inflammation

Start date: August 26, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT03545386 Recruiting - Pouchitis Clinical Trials

Fecal Microbiota Transplantation for Pouchitis

Start date: April 17, 2019
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03524352 Recruiting - Pouchitis Clinical Trials

the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

POCA
Start date: March 12, 2020
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available. Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.