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Enteritis clinical trials

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NCT ID: NCT05831176 Recruiting - Clinical trials for Eosinophilic Gastritis

A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

ENGAGE
Start date: May 3, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

NCT ID: NCT05800704 Recruiting - Clinical trials for C. Difficile Enteritis

Support of Colonization Resistance of the Gut Microbiota With the Synbiotic Food Supplement Nagasin®

Start date: March 10, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement Nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment. The main question is whether Nagasin® can prevent any increase in abundance of C.difficile within the first four weeks after antimicrobial treatment for a C. difficile infection. Participants will receive Nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a C. difficile episode.

NCT ID: NCT05728060 Recruiting - Radiation Enteritis Clinical Trials

Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis

Start date: December 1, 2022
Phase:
Study type: Observational

To explore the fecal bile acid profile of patients with radiation enteritis, to clarify the types of bile acids that are closely related to the occurrence of radiation enteritis; to explore the interaction between fecal bile acids and intestinal flora in patients with radiation enteritis, and to lay the foundation for further elucidation of the pathogenesis of radiation enteritis.

NCT ID: NCT05425901 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids

INTRUST
Start date: September 19, 2022
Phase: N/A
Study type: Interventional

This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).

NCT ID: NCT05251909 Completed - Clinical trials for Eosinophilic Gastroenteritis

Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

HUDSON GI
Start date: January 18, 2022
Phase: Phase 3
Study type: Interventional

This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.

NCT ID: NCT05229432 Recruiting - Gastroparesis Clinical Trials

Study of Gastric Motility in Eosinophilic Gastritis

OAT-FEED
Start date: January 25, 2023
Phase:
Study type: Observational

Purpose: The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment. Hypothesis: Gastric dysfunction occurs in the natural history of EG but is underdiagnosed due, in part, to contraindications to the use of the standard meals used in gastric emptying studies.

NCT ID: NCT05214768 Active, not recruiting - Clinical trials for Eosinophilic Gastroenteritis

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis

Start date: March 4, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.

NCT ID: NCT05152563 Withdrawn - Clinical trials for Eosinophilic Gastritis

A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis

ENIGMA-SC
Start date: December 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies.

NCT ID: NCT05138887 Recruiting - Radiation Enteritis Clinical Trials

A Study for Assessing the Efficacy and Safety of BH4 in Radiation Enteritis

Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This present study envisaged a single-center, prospective, open-label, placebo and randomized controlled phase II clinical study to assess the efficacy and Safety of Tetrahydrobiopterin in Treating Radiation Enteritis in Gynecological Cancer Patients.

NCT ID: NCT05084807 Recruiting - Healthy Volunteers Clinical Trials

Evaluation of the Lymphocyte Subpopulations in the Normal Mucosa of the Upper Digestive Tract

GUTproject
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The macro and microscopic findings of the upper gastrointestinal tract are useful in the differential diagnosis of digestive diseases such as Crohn's or celiac diseases. However, the histopathological findings (duodenal lymphocytosis, atrophy, chronic inflammatory infiltrate, etc.) are generally not pathognomonic, and there is a great overlap between different inflammatory diseases. The study of lymphocyte subpopulations of the intestine has shown its usefulness in cases of celiac disease that are difficult to diagnose. In patients with celiac disease, lymphocytes that infiltrate the duodenum present a specific pattern with increased percentage of TCRgẟ+ lymphocytes and reduced percentage of CD3- lymphocytes. However, it is currently unknown if other inflammatory diseases (e.g. Crohn's disease) have specific lymphocyte subpopulations that could be of great diagnostic aid. One of the main problems in establishing patterns associated with disease is the absence of immunological studies carried out in healthy individuals. Most of the studies include, as a control group, patients who undergo gastroscopy for the study of upper digestive symptoms and have microscopically normal duodenal biopsy. This is a heterogeneous population that includes, among others, patients with functional pathology in whom the existence of low-grade inflammatory phenomena has been suggested. Therefore, patients with digestive symptoms are not good controls to establish normal patterns of intestinal immunity.