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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying a condition known as not-celiac wheat sensitivity (NCWS), which affects adults with irritable bowel syndrome (IBS)-like symptoms that improve on a gluten-free diet but worsen when gluten is reintroduced. NCWS patients do not have celiac disease or wheat allergy, and the study aims to better understand the biochemical, immunological, and histological features of this condition. The research also seeks to identify markers that could help diagnose NCWS and clarify its underlying causes. Participants will be adults aged 18 to 65 who have experienced symptom improvement on a gluten-free diet and tested negative for celiac disease and wheat allergy. After at least one month on a gluten-free diet and being symptom-free, participants will be randomized in a double-blind, placebo-controlled trial to receive either wheat flour or placebo three times daily for 15 days. Some may follow a more restricted elimination diet to exclude other food sensitivities before starting the intervention. During the study, researchers will assess gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale and collect blood, fecal samples, and tissue biopsies from the esophagus, duodenum, and colon. These evaluations will be done before and after the dietary challenge to observe changes. The main outcome is the change in symptoms from baseline after two weeks. The study involves detailed monitoring to identify potential biomarkers and better understand the disease process in NCWS patients.
Actively Recruiting
Researchers are evaluating the effects of prismatic adaptation combined with Serious Games on cognitive and behavioral deficits in patients who have experienced traumatic brain injury (TBI). The study compares this novel rehabilitation protocol to a training program using Serious Games without prismatic adaptation. The aim is to assess how these treatments impact cognitive functions like attention, memory, and executive abilities, as well as functional cognitive outcomes. The study involves patients admitted within 90 days of TBI onset, focusing on those with moderate cognitive functioning levels. Participants will be randomly assigned to two groups. The experimental group will receive prismatic adaptation treatment (PAT) involving pointing exercises with prismatic lenses using an 11-inch tablet, alternating rightward and leftward prism deviation over 10 sessions in 2 weeks. Each session includes 10 minutes of prismatic adaptation followed by 30 minutes of cognitive training using Serious Games designed to improve attention, memory, inhibition, and planning. The control group will engage in the same Serious Games without the prismatic adaptation. Both groups also receive standard cognitive rehabilitation using paper and pen materials. Sessions last about one hour, five days a week, for two weeks. Participants will be assessed before treatment and after completing 10 rehabilitation sessions. Assessments include neuropsychological tests and resting-state EEG to observe changes in brain activity. The main outcome measured is cognitive improvement from enrollment to treatment completion at two weeks. Safety monitoring is minimal due to low risk, and all data are securely stored. After the study treatment, both groups continue standard cognitive and motor rehabilitation. The total participation duration corresponds to the hospital stay during rehabilitation.
Actively Recruiting
Non-celiac wheat sensitivity (NCWS) is a condition where people experience intestinal and other symptoms after eating wheat, without having celiac disease or wheat allergy. This condition is increasing worldwide and may be linked to wheat breeding changes, such as higher gluten content in modern wheat. Researchers aim to determine if ancient wheats are better tolerated by NCWS patients than modern wheats, and to identify which wheat components trigger symptoms. The study focuses on inflammatory responses to different wheat proteins and explores various wheat types, including genetically modified wheat with lower amylase/trypsin inhibitors (ATIs).