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Colitis clinical trials

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NCT ID: NCT05791526 Recruiting - Ulcerative Colitis Clinical Trials

An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan

Start date: December 19, 2022
Phase:
Study type: Observational

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult participants will be enrolled in Japan. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 60 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05791487 Recruiting - Ulcerative Colitis Clinical Trials

Combination of Diet and Oral Budesonide for Ulcerative Colitis

ReDUCE
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula. The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.

NCT ID: NCT05786404 Recruiting - Clinical trials for Active Ulcerative Colitis (UC)

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

Start date: December 15, 2023
Phase: Phase 1
Study type: Interventional

The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

NCT ID: NCT05785715 Recruiting - Ulcerative Colitis Clinical Trials

Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis

Start date: April 24, 2023
Phase: Phase 2
Study type: Interventional

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT05784246 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

SHINE-2
Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT05782907 Recruiting - Ulcerative Colitis Clinical Trials

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05781698 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

Start date: March 20, 2023
Phase: Phase 2
Study type: Interventional

Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent

NCT ID: NCT05780723 Recruiting - Ulcerative Colitis Clinical Trials

Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)

QHQYP
Start date: April 4, 2023
Phase: N/A
Study type: Interventional

This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. The modified Mayo Activity Index will be used as the main evaluation index. Secondary evaluation indices will include the Underwater Endoscopic Severity Index (UCEIS) score, endoscopic Baron score, mucosal histological score (Geboes index), Chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. Safety indicators were also monitored.

NCT ID: NCT05770609 Recruiting - Clinical trials for Mild to Moderate Ulcerative Colitis

A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

Start date: June 19, 2023
Phase: Phase 2
Study type: Interventional

To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.

NCT ID: NCT05767021 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

LUCENT-URGE
Start date: May 17, 2023
Phase: Phase 3
Study type: Interventional

A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.