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Ulcer clinical trials

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NCT ID: NCT06084624 Not yet recruiting - Clinical trials for Oral Ulceration Due to Behçet's Disease

Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease

Start date: December 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on oral ulcer severity in patients with Behcet's disease.. The main question it aims to answer is : What is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash in management of oral ulcers in Behcet's disease? Participants will will be divided randomly into the two groups and the following outcomes will be measured: The oral ulcers severity Pain associated with oral ulcers Number of oral ulcers Healing time of oral ulcers

NCT ID: NCT06080048 Recruiting - Ulcerative Colitis Clinical Trials

A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

Start date: October 24, 2023
Phase: Phase 1
Study type: Interventional

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

NCT ID: NCT06077955 Recruiting - Ulcer Peptic Clinical Trials

Ulcers Formation After Hand-Sewn vs Stapled Gastrojejunal Anastomosis In MGB.

ULTRA
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

We assume that the frequency of gastrojejunostomy ulcers after MGB-OAGB is associated with the peculiarities of the side-to-side gastrojejunostomy (GJS) formation, which is currently the "gold standard" for this procedure. The geometry of such anastomosis leads to the formation of a narrow strip of the gastric wall between two stapler lines (between the suture from the 2nd cassette during the formation of the "small ventricle" and directly from the suture from the cassette during the GJS formation). Perhaps this section of the stomach wall is prone to ischemia, which can certainly increase the risk of ulcer formation. It is also possible that a zone with impaired blood supply may also form in the "blind pocket" above the anastomosis. When forming a Hand-Sewn GJS of the end-to-side type, ischemia zones do not occur. The anastomosis has a more physiological geometry, there is no conflict between the lines of stapled sutures. Thus, we put forward the assumption that a serious risk factor for the development of a GJS ulcer was eliminated when switching to a completely manual technique for the GJS formation when performing MGB-OAGB. The study is aimed at the compare the incidence of GJS ulcers during MGB-OAGB, depending on the techniques of anastomosis formation.

NCT ID: NCT06073873 Recruiting - Ulcerative Colitis Clinical Trials

A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

Start date: May 30, 2024
Phase:
Study type: Observational

The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.

NCT ID: NCT06071312 Recruiting - Ulcerative Colitis Clinical Trials

FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach

Start date: September 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI. The prevalence of recurrent CDI in patients with IBD is 2.5 to 8 times higher than in the general population, with a cumulative lifetime risk of 10 %. The higher risk to the development of CDI in patient with IBD is directly related to the microbiome alterations that are associated with this chronic disoder. Moreover, the use of antibiotics to cure CDI further worsens the gut microbiota, triggering potentially a self-maintaining cycle and predisposes such patients to a higher risk of recurrence. In these patients, CD superinfection is associated, with an increased rate of hospitalization, length of stay, the need to modify the treatment to the underlying disease, the increase rate of colectomy, there higher mortality rate, with a net increase of health costs. Nowadays, as emerged by several studies FMT has been established as a valid treatment option against recurrent CDI (rCDI), and it is recommended by international guidelines. Unfortunately, most FMT studies for rCDI have excluded patients with IBD. Recent evidence suggests that FMT is effective in patients with ulcerative colitis (UC) and concomitant rCDI, both in the treatment of the infection and in the improve of disease activity. To date, most studies evaluated the efficacy of single infusion of FMT in these patients. Preliminary data from our group suggest that a sequential approach (i.e., repeated fecal infusions) may increase the efficacy of FMT in this population. Indeed, in 18 patients with IBD, single infusion fecal resulted in eradication of rCDI in 60% of cases, whereas this outcome was achieved in 89% of cases using a sequential approach. Similar data have been demonstrated in a retrospective study by Fischer and colleagues. However, more studies are advocated to confirm these results. Therefore, our study aim to compare the efficacy of single FMT vs. sequential in the eradication of rCDI in patients with UC.

NCT ID: NCT06067698 Not yet recruiting - Ulcerative Colitis Clinical Trials

Alpha Lipoic Acid in Ulcerative Colitis

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

This study aims at evaluating the efficacy and safety of alpha-lipoic acid as adjuvant therapy to mesalamine in patients with mild to moderate ulcerative colitis due to its effect as anti-oxidant and anti-inflammatory drug which can help to improve disease.

NCT ID: NCT06067022 Completed - Diabetic Foot Ulcer Clinical Trials

Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers

Start date: January 5, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are: - Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving? - What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers? Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.

NCT ID: NCT06065488 Completed - Foot Ulcer Clinical Trials

Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients

Start date: October 6, 2023
Phase: N/A
Study type: Interventional

This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen general Hospital and El Rahma - private clinic. All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

NCT ID: NCT06052059 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

NCT ID: NCT06050811 Recruiting - Ulcerative Colitis Clinical Trials

Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)

PRInCE-UC
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The community of microbes living in the gut is called the 'gut microbiome'. Changing this could be an exciting new way of treating people living with ulcerative colitis (UC). UC is a type of inflammatory bowel disease. It affects 4 in every 1000 people in the UK. UC causes severe episodes of inflammation leading to bloody diarrhoea. The gut microbes of people living with UC are different to those in healthy people. This may be part of the reason people with UC have a more inflamed gut. Prebiotics are types of fibre in the diet which help feed the positive microbes in the colon. Eating them can change the make-up and activity of the bugs which live in our gut in a good way. The goal of this clinical trial is to test the effect of a type of prebiotic called a human milk oligosaccharide (HMO) on the symptoms of patients with UC. The main questions it aims to answer are: - Can a prebiotic improve symptoms for patients living with UC? - Can a prebiotic improve the gut microbiota of people living with UC, and improve markers of inflammation, metabolism and immune function? Patients will take a sachet containing either the prebiotic or a placebo for four weeks, then swap to the other sachet. The trial will be double-blind and randomised. This 'crossover' design means patients act as their own control, which is important in gut microbiology studies. The prebiotic's effect on patient symptoms, metabolism and immune system will be measured. The investigators plan to recruit 44 participants over 18 months. Their urine, blood and stool will be tested. This project will be the first 'bench to bedside' study into the use of prebiotics in IBD. The treatment in this project is rooted in gut model studies. Different prebiotics were tested in the lab to determine which was the best to use for the trial. This 'lab first' approach is a first of its kind.