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231 active trials for Ulcerative Colitis

Diet Treatment of Patients With Ulcerative Colitis in Remission

The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.

Start: July 2018

Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNF?). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls Interaction between these proteins and biologics in breast milk of women with IBD Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNF? and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.

Start: July 2017

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.

Start: April 2018

Identification of Biomarkers of Tofacitinib Therapy in Patients With Ulcerative Colitis

This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to tofacitinib therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating tofacitinib therapy according to standard of care. This study consists of: The main study: Part 1: 8-week induction therapy followed by an 8-week maintenance therapy Part 2: Patients who continue tofacitinib therapy after part 1 will be followed further for a total of 2 years, or until discontinuation of tofacitinib therapy (whichever is first) The pharmacokinetic and pharmacodynamic substudy: Patients who consent to the substudy will be randomized (up to 30 subjects maximum) into 1 of 5 arms (different sampling time points), where pharmacokinetics and pharmacodynamics will be analyzed on day 1, week 4, and week 8 of induction of tofacitinib therapy

Start: August 2020

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.

Start: December 2016

Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled, multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving immunosuppressants and present mild-to-moderate activity of the disease. Enrolled patients would receive standard high doses of 5-ASA (4g), according to current clinical guidelines, and are randomized to receive also PBF-677 or placebo.

Start: July 2018

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.

Start: April 2021

Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

Muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. Children with inflammatory bowel disease (IBD) have lower level and intensity of physical compared to a control group. Several studies have shown that children with IBD have a lower bone mineral density (BMD) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of fracture. A recent observational study found a positive and significant correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

Start: March 2020

A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis

This will be a phase I/IIa, open-label, three-stage, single center study aimed at investigating the safety, the efficacy (clinical and endoscopic effects) and the pharmacokinetics of Niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with mild-to-moderate UP and UPS, defined as a Modified Mayo Score (MMS) ? 4 and < 8, with a stool frequency subscore (SFS) ? 1, a rectal bleeding sub-score (RBS) = 1 or 2, and an endoscopic subscore (mucosal appearance) = 1 or 2. At the endoscopic sub-score any degree of friability will be classified as having a sub-scale score of 2.

Start: May 2018

Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients

An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. A recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients. It is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician. The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.

Start: December 2019

Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.

Start: July 2016

Gut Microbiome in Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic inflammatory condition for gastrointestinal tract. There have been numerous studies to reveal dysbiosis of fecal/mucosal microbiome composition in IBD patients but actual trend of dysbiosis is strikingly different among patient's ethnicity. In this background, the investigators have composed a prospective cohort of Korean IBD patients in a large academic referral IBD center. Using an integrated multi-omics bioinformatic analysis, the investigators aim to explore gut microbial signatures along with distinct clinical/genetic features, and their potential interplay in patients with IBD.

Start: April 2018

Analysis of Intestinal Defensin Expression in Acute GVHD

This study has the aim to analyze intestinal expression of endogenous antimicrobial peptides in patients with acute GVHD. The expression will be compared to intestinal expression of defensins in patients with colitis and patients without intestinal inflammation.

Start: September 2018

Individualization Treatment Through a Self-managed Web-based Solution in Ulcerative Colitis

This study investigates the effect of individualized monotherapy with Mesalazine (Pentasa Sachet ®) on time to remission in patients with mild to moderate UC in an eHealth setting.

Start: December 2019

Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

Hypothesis: Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

Start: December 2018

Clinical Database of Colorectal Robotic Surgery

Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

Start: June 2018

Low Sulfur Fecal Transplant for Ulcerative Colitis

The purpose of this study is to evaluate the engraftment of donor microbiota's sulfate reducing bacteria (SRB) in subjects with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). Specifically this study will evaluate if low SRB donor microbiota translates to lower SRB microbiota in the UC recipient. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. Patients with UC have a higher relative abundance of SRB compared to healthy controls. It is the aim of this study to determine if the microbiota in UC can be altered to favor a low SRB fraction.

Start: July 2019

Transcutaneous VNS to Treat Pediatric IBD

The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal nerve stimulation (VNS). Research has previously identified that VNS using a surgically implanted stimulator can improve symptoms and decrease inflammation in people with inflammatory diseases. This study will evaluate the use of non-invasive nerve stimulation through the skin (rather than through an implanted device) as a potential therapy in pediatric patients with Crohn Disease or ulcerative colitis. We will be evaluating how this nerve stimulation affects symptoms, markers of inflammation found in the blood and stool including cytokine levels, and heart rate variability. The primary hypothesis of the study is the use of transcutaneous VNS will decrease inflammation in people with IBD leading to improved signs and symptoms of disease. The primary endpoint of the study is to evaluate the change in fecal calprotectin after 16 weeks of nerve stimulation. Secondary endpoints include changes in symptom scores, blood cytokine levels, and heart rate variability.

Start: February 2019

ENhancing Recovery in CHildren Undergoing Surgery

Initiated in the 1990s, perioperative Enhanced Recovery Protocols (ERPs) have progressively gained traction in a wide range of adult surgical disciplines and have decreased hospital length of stay (LOS), in-hospital costs, complications, and result in a markedly improved patient care experience that mitigates the physiologic stress of surgery and hastens recovery. Implementation of ERPs in pediatric surgery is lagging and concerted efforts to demonstrate both clinical effectiveness and to examine obstacles to implementation are needed. Specifically, pediatric patients with inflammatory bowel disease (IBD) undergoing elective abdominal surgery represent an ideal population in which to study the implementation of ERPs. Almost one third of patients with Crohn's disease (CD) and a quarter of patients with Ulcerative Colitis (UC) present before age 20. Up to three-quarters of CD patients require GI surgery for medically refractory disease and all patients with UC require colectomy to either manage severe disease or to mitigate cancer risks. Over the past four years, investigators modified existing adult ERPs to meet the needs of pediatric patients undergoing elective GI surgery. Based on the positive results of a pilot study, the investigators propose to conduct a multicenter, prospective, pragmatic, study using a stepped-wedge, cluster, randomized controlled trial design to evaluate the effectiveness of ERPs while assessing implementation fidelity, sustainability, and site-specific adaptations. The cluster randomized trial design is ideally suited for this type of pragmatic intervention implementation. The National Implementation Research Network's five Active Implementation Frameworks (AIFs), which identifies competency, organization, and leadership as drivers of implementation, empowers team collaboration, and facilitates rapid-cycle evaluation, will be used to optimize implementation. The investigators propose to conduct the ENhancing Recovery In CHildren Undergoing Surgery (ENRICH-US) Study in 18 US hospitals participating in the Pediatric Surgical Research Collaborative (PedSRC) by implementing and evaluating the effectiveness of the Pediatric ERP in GI Surgery on clinical outcomes for pediatric IBD patients and by measuring by fidelity and sustainability of the intervention while identifying organizational, leadership, and competency-based drivers of improved ERP implementation and sustainability.

Start: September 2019

High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy. This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.

Start: April 2019