Celiac Disease

This research aims to evaluate the safety, tolerability, and nutrient absorption of the RELiZORB enzyme cartridge in children aged 2 to 18 years with Short Bowel Syndrome (SBS) who depend on parenteral nutrition (PN). SBS causes inadequate intestinal absorption due to significant loss of small bowel, requiring intravenous nutrition to maintain hydration and nutrition but leading to complications such as liver failure. The study explores whether predigesting fats with RELiZORB can improve absorption and reduce reliance on PN. The RELiZORB device is an enzyme cartridge connected to enteral feeding tubes that mimics pancreatic lipase to digest fats before they enter the gut, aiming to improve fat absorption without the need for bile acid emulsification. Participants will receive tube feeding through the device daily for 90 days. The study monitors changes in PN calories over time, along with growth, fecal fat, plasma fatty acids, and nutrition intake. Participants will be assessed at multiple time points during the 90-day treatment to evaluate PN calorie reduction and nutritional status. Safety and tolerability will be monitored by recording adverse events. The study involves regular clinical visits, laboratory tests, and nutrition assessments to measure the effectiveness of RELiZORB in improving enteral nutrition absorption and supporting growth while reducing PN dependence.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors (TCRs) to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohn's disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are evaluating the safety of a single oral dose of HB-2121 in adults with suspected celiac disease. This Phase 1 trial aims to understand what side effects participants may experience and how the drug interacts with the small intestine. The study is sponsored by Nielsen Fernandez-Becker and includes adults aged 18 to 75 undergoing diagnostic procedures for celiac disease. Participants will receive one 250 mg dose of HB-2121 four hours before a standard esophagogastroduodenoscopy (EGD). The study involves four in-person clinic visits for checkups and lab tests, along with two remote visits focusing on safety lab assessments. Participants will also complete a daily questionnaire for a week about their symptoms and overall health. During the 30 days following dosing, researchers will monitor safety by tracking any adverse events. They will also measure specific markers in the small intestine using microscopy shortly after dosing. The study includes regular health monitoring, laboratory tests, and questionnaires to assess participant well-being and drug behavior over the study period.

Frailty is a common condition in older adults that can increase the risk of poor health outcomes such as falls, hospital stays, and death. This research aims to study how assessing frailty before a colonoscopy might affect patient satisfaction and the number of colonoscopies avoided. The study is a prospective randomized controlled trial involving patients over 65 years old at Princess Alexandra Hospital, comparing a personalized approach using a frailty assessment to standard care. Participants will be randomly assigned to one of two groups. One group will receive a personalized approach that includes a frailty assessment using tests like grip strength, sit-to-stand timing, balance, and gait speed, along with questionnaires about medical conditions. The gastroenterologist will discuss the results and risks with the patient to help decide about having a surveillance colonoscopy. The other group will receive standard care, which involves discussing the benefits and risks of colonoscopy without the frailty assessment. During the study, participants will complete satisfaction questionnaires at the time of consultation and within weeks after any colonoscopy procedure. Researchers will track how many patients choose to avoid colonoscopy after receiving information and will monitor colorectal cancer-related complications and other causes of death within five years. The study will assess how the personalized approach may impact decision-making and patient satisfaction with outpatient services related to colonoscopy care.

Researchers are evaluating a combined screening and follow-up management approach for gastrointestinal tumors. This study aims to explore and assess the feasibility and cost-effectiveness of screening for esophagus, stomach, and colorectal cancers in a population-based, multicenter setting. The trial includes participants aged 45 to 70 years and will observe outcomes over a 10-year follow-up period. Participants are divided into groups undergoing different screening methods. Group one receives gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori antigen test, RNF180 and SEPTIN9 gene methylation tests, along with an investigation of various risk factors such as past diseases, lifestyle habits, family cancer history, and reproductive status. Group two undergoes risk factor investigation, FIT, and Helicobacter pylori antigen stool test; if positive, further gene methylation tests and possibly colonoscopy are conducted. Control groups matched by spouse or sibling undergo only risk factor investigations. During the study, participants provide information on medical history, lifestyle habits, and family cancer history. Screening tests including endoscopies, stool tests, and gene methylation analyses are performed as specified. Researchers will monitor the detection of cancer or precancerous lesions over 10 years, tracking health outcomes and the effectiveness of combined screening. Safety and adherence are observed throughout the follow-up.

Researchers are evaluating the effectiveness and cost-efficiency of early remote interventions for patients with severe, chronic, or relapsing gastrointestinal symptoms that lack clear explanation and who are waiting for care in an integrated clinic. The study uses a two-stage randomization to compare different approaches, aiming to improve symptom management, identify which patients respond best to certain treatments, and assess acceptance of new care models. About 200 patients will initially have their symptoms and wheat intolerance assessed remotely. Participants who continue to experience symptoms after initial assessment will be randomly assigned to one of four pre-consultation interventions: a standardized dietician-supervised program, an exercise program, internet-delivered cognitive behavior therapy, or no intervention. Following this, they will be randomized again to receive either a consultant-led outpatient clinic consultation or care in an integrated clinic, depending on their response to the pre-consultation intervention. Throughout the study, participants will be regularly assessed using a structured gastrointestinal symptoms score and quality of life measures, collected at multiple time points up to 44 weeks. Additional evaluations include anxiety and depression scales, microbiome analysis, and acceptance of care models by patients and staff. Cost-effectiveness will also be tracked. The total participation involves remote interventions, clinical consultations, and multiple assessments over time to monitor symptoms, quality of life, and treatment impact.

Researchers are evaluating a new nutritional supplement's effects on nutrient gaps, nutrient status, and gut microbiome health in adults using glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This triple-blind, placebo-controlled, randomized trial involves 120 participants aged 18 to 59 years. The study aims to better understand how this supplement might influence nutrition and gut health among GLP-1 RA users. Participants are randomly assigned to receive either the AG1 nutritional supplement or a placebo made of maltodextrin. The study maintains triple blinding to ensure unbiased results. The treatment period lasts 90 days, during which participants follow their usual GLP-1 RA maintenance dose without changes. The trial monitors nutrient gaps, nutrient status markers, and gut microbiome changes at the end of this period. Throughout the study, participants must adhere to specific protocols including maintaining current diet, sleep, and activity levels, avoiding new supplements or medications, and following pre-test restrictions such as fasting and avoiding caffeine and exercise before blood tests. Researchers collect data on nutrient and microbiome outcomes and monitor adherence through reported behaviors and weighing scale access. The total participation duration is 90 days, with detailed assessments to evaluate the supplement's impact safely and accurately.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend called FODZYME® on gastrointestinal symptoms in adults who experience self-reported bloating. The study focuses on how this enzyme blend affects symptoms such as bloating and abdominal pain, which are often triggered by fermentable carbohydrates known as FODMAPs. This is a randomized, double-blind, placebo-controlled crossover trial that aims to provide a more flexible alternative to the restrictive Low FODMAP Diet by breaking down FODMAPs before they ferment in the colon. Participants will take the enzyme blend or a placebo with each meal, snack, or substantial beverage, applying it directly to their food. The trial is divided into two main periods: half the participants will start with the enzyme blend for four weeks followed by a two-week washout and then switch to placebo for another four weeks; the other half start with placebo and then switch to the enzyme blend after the washout. The study product is designed to target specific FODMAPs like fructan, GOS, and lactose and is intended for adults with or without IBS symptoms. During the study, participants will complete daily questionnaires and assessments over about 19 weeks, including patient-reported outcome measures for bloating, gastrointestinal symptoms, abdominal pain, food-related quality of life, and anxiety. The study is conducted remotely, allowing participants to complete assessments at home using a smartphone app. Safety is monitored by excluding those with known allergies to corn or previous reactions to digestive enzyme supplements, and researchers will review changes in bloating symptoms as the primary outcome.