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Ulcer clinical trials

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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: 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.

NCT ID: NCT06049017 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

ANTHEM-UC
Start date: October 9, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

NCT ID: NCT06042933 Recruiting - Clinical trials for Peptic Ulcer Perforation

Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population & Sample size :(

NCT ID: NCT06037369 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Short Message-based Customized Standardized

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life. The short message-based customized standardized patient education program combines several smartphone message-based standardized educational contents to construct a customized patient education program which is according to the needs of patients, thus providing individualized patient education in a timely manner

NCT ID: NCT06035536 Recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

Start date: June 8, 2023
Phase: N/A
Study type: Interventional

The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

NCT ID: NCT06035523 Recruiting - Diabetic Foot Clinical Trials

Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

Start date: December 29, 2021
Phase: N/A
Study type: Interventional

Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.