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Gluten Sensitivity clinical trials

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NCT ID: NCT05803408 Recruiting - Celiac Disease Clinical Trials

RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.

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

The investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Pilot study means that it will recruit a low number of participants to see if it is possible to perform the study, and to estimate how many participants will be needed for the large study. The study will collect information through questionnaires that assess gut symptoms, quality of life, mood changes and dietary patterns. Moreover, the study will collect data on tests done during clinic visits to check the status of patients' celiac markers and nutritional status (such as vitamins and minerals). Physical exam will also take place, and include measurement of weight, BMI and body composition in a 3D scanner. The dietitian will analyze patients' diet at each visit during the study period. Given the lack of evidence on timing of introduction of gluten-free oats for patients with a recent celiac diagnosis, and the potential risks of limiting oats in a gluten-free diet, the results will hopefully lead to better understanding of whether one strategy has a benefit over the other.

NCT ID: NCT05644782 Recruiting - Psoriasis Clinical Trials

Dietary Approach to Mild-to-moderate Psoriasis

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

Psoriasis is a systemic chronic inflammatory immune-mediated disease whose etiopathogenetic mechanisms involve genetic predisposition, and immunological and environmental factors. Its prevalence is about 3% in adults, and it is characterized by well-demarcated, erythematous plaques, covered by silvery-white scales, in elbows, knees, trunk, and scalp. However, psoriasis is far from being considered just a dermatologic condition because the cytokine's cascade, which lays behind its inflammatory and immune-mediated pathogenesis, can determine multiple systemic manifestations. In addition, several patients with psoriasis often complains of gastrointestinal (GI) symptoms. Therefore, authors focused their attention over the gut-skin axis and its possible pathogenetic and immunoregulatory role in psoriasis (i.e., altered gut barrier, increased blood concentration of gut microbiota-derived metabolites, systemic inflammation). In this context, several dietetic approaches (e.g., Mediterranean, low calories, protein-restricted, vegetarian diets, and gluten-free diet, GFD) have shown a certain efficacy in improve psoriasis cutaneous and systemic manifestations. In recent years, the existence of a wheat-related disorder in patients who do not suffer from CD or wheat allergy (WA) has been definitively ascertained and defined as Non-Celiac Wheat Sensitivity (NCWS). Its prevalence in the general population is unknown, but self-reported NCWS is around 10%. This condition is characterized by both GI and extraintestinal symptoms, which are triggered by wheat ingestion. In these patients, wheat ingestion might lead to alteration in intestinal permeability and gut microbiota and to systemic immune activation and inflammation. Based on the evidence of gut involvement in the pathogenesis and clinical manifestation of psoriasis, as well as on the ability of gluten/wheat to increase intestinal permeability, it could be hypothesized that gluten/wheat may represents one of the pathogenetic environmental factors of psoriasis and that its intake may be able to worsen symptoms in affected patients. The investigators hypothesize that a wheat-free diet (WFD) can reduce the inflammatory state and ameliorate the clinical symptoms in psoriasis patients. The successive clinical and immunologic reaction to the re-exposure to wheat ingestion, performed by an open challenge, will be also evaluated to confirm a wheat-dependent mechanism and to understand the underlining physiopathology.

NCT ID: NCT05555446 Recruiting - Celiac Disease Clinical Trials

Bovine Colostrum to Prevent Absorption of Gluten

Start date: September 22, 2022
Phase: Early Phase 1
Study type: Interventional

To investigate the use of hyperimmune bovine colostrum to reduce gluten absorption. A double-blind, cross-over study will be performed in which persons who are following a strict gluten-free diet will be challenged with oral gluten with or without the bovine colostrum.

NCT ID: NCT05209568 Recruiting - Celiac Disease Clinical Trials

Immune Responses to Gluten

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

NCT ID: NCT04247737 Completed - Gluten Sensitivity Clinical Trials

Gluten Free Diet in IBS

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.

NCT ID: NCT03771443 Completed - Gluten Sensitivity Clinical Trials

Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease

Start date: July 21, 2019
Phase: Phase 3
Study type: Interventional

Celiac disease (CD) is the most common genetically based food intolerance in the world, with a prevalence among approximately 1% of the general population (Guandalini & Assiri, 2014). CD is a frequent disorder among Egyptian children, both in the general population and in at-risk groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong adherence to a strict gluten free diet (GFD) remains the only available treatment for patients with CD and typically results in a complete return to health. Nevertheless, gluten is not found only in diet, Gluten is commonly used as a binder in products like medication, cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes and other oral health products and it can be swallowed by mistake and initiate immune response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste in Egypt has become mandatory.

NCT ID: NCT03678935 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Effect of FODMAP Restriction on Persistent GI-symptoms in Coeliac Patients

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.

NCT ID: NCT03644069 Active, not recruiting - Autoimmune Diseases Clinical Trials

A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Start date: August 6, 2018
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

NCT ID: NCT03638544 Completed - Clinical trials for Irritable Bowel Syndrome

Reduced Content of Gluten Diet on Patients With Irritable Bowel Syndrome (Pro.Ali.Fun.)

PROALIFUN
Start date: January 1, 2014
Phase: N/A
Study type: Interventional

This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).

NCT ID: NCT03543540 Completed - Celiac Disease Clinical Trials

Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).