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Hypersensitivity clinical trials

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NCT ID: NCT01762579 Recruiting - Clinical trials for Not-celiac Wheat Sensitivity

Bio-markers of Not-celiac Wheat Sensitivity

Start date: January 1, 2012
Phase: N/A
Study type: Interventional

The aim of the investigators' study is to evaluate biochemical, immunological and histological characteristics of patients affected with the so-called "gluten (or wheat) sensitivity" who suffers from irritable bowel syndrome (IBS)-like symptoms. As it is not known what component of the cereals causes the symptoms in so called "gluten-sensitive" patients, the investigators prefer to speak of "not-celiac wheat sensitivity" (NCWS). NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our research, we will select adult patients, both genders, affected with suspected NCWS (i.e. with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing negative for celiac disease [anti-tissue transglutaminase antibodies, anti-tTG, and anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1] and wheat allergy [serum specific IgE for wheat]). The patients will be recruited at the Department of Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the University of Palermo, from January 2012 to October 2013, for IBS-like symptoms. At the time of the recruitment, the patients will be on GFD by at least one month and must be asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and other foods) could be prescribed in patients who are suspected to suffer from multiple food hypersensitivity. The patients will be randomized to undergo a double-blind placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days. Before and after the challenge, the investigators will evaluate gastrointestinal (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood and fecal sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and rectoscopy, with multiple biopsies), for the identification of possible markers (serological, biochemical, immunological, histological features, expression of cytokines and other constitutive mucosal proteins from peripheral blood mononuclear cells, mucosal lymphocytes and fecal biomarkers) that may be of help to diagnose the condition of NCWS and to understand its pathogenesis.

NCT ID: NCT01583907 Recruiting - Food Allergy Clinical Trials

Nutrition in Children With Food Allergy

Start date: March 2012
Phase: Phase 0
Study type: Observational

The investigators aim to asses the effect of dieto-therapy and of nutritional counseling on the nutritional status, body growth and tolerance acquisition in children with cow's milk allergy.

NCT ID: NCT01503060 Recruiting - Pain Clinical Trials

Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

Start date: December 2011
Phase: Phase 3
Study type: Interventional

The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.

NCT ID: NCT01477957 Recruiting - Obesity Clinical Trials

The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism

BARIA-DDZ
Start date: September 2012
Phase:
Study type: Observational

The purpose of this study is: 1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid storage can be improved by bariatric surgery 2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in patients with obesity (degree 2-3) 3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is associated with the degree of liver inflammation

NCT ID: NCT01429896 Recruiting - Clinical trials for Peanut Hypersensitivity

The Effect of Extrinsic Factors on Food Allergy

Ex-Factor
Start date: October 2012
Phase: Phase 2
Study type: Interventional

Food allergy is a common problem, affecting 5-8% of the population. Peanut allergy causes reduced quality of life due to the perceived high risk of severe reactions. Patients rely on accurate labeling of both loose and pre-packed foods, but these are often ambiguous and unhelpful. There is a common conception that labeling is 'over-cautious'. Peanut-allergic consumers face increasingly restricted food choices in complying with this advice due, in part, to the proliferation of advisory labels such as 'may contain peanuts'. This contributes to the reduces quality of life of affected individuals. For industry to provide more accurate and helpful labeling, certain characteristics of the food-allergic population need to be defined. Firstly, the minimum 'eliciting dose' for the population has been estimated by studying large groups of peanut allergic patients who are challenged with peanut ingestion in increasing amounts. From these, an eliciting dose that provokes a reaction in 10% of the food-allergic population has been estimated at between six and 14mg of peanut protein. Translation of population eliciting doses (ED) into acceptable levels of allergen contamination for the population requires consideration of a 'safety factor'- to account for individual variability in dose threshold and severity. Data suggest such variability depends in part on extrinsic factors (exercise and sleep restriction). Each factor may have a different effect in scale and direction. The investigators are proposing a cross-over trial with 85 peanut-allergic adults who will each undergoing a baseline peanut challenge followed by repeat challenges with extrinsic factors applied, in random order (repeat baseline, +exercise and +sleep restriction). These data will further define ED for the UK population and a safety factor derived from shift in threshold, to inform industry and protect the allergic population.

NCT ID: NCT01175759 Recruiting - Abortion, Recurrent Clinical Trials

Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss

Start date: June 2010
Phase: Phase 2
Study type: Interventional

The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedure inducing a tolerance to the hormones the women are sensitive to. This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy Loss (URPL) and in Control parous, healthy women. The Skin Test Panel includes four female hormones and three control solutions. Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the subject's menstrual cycle. The skin reactions are examined by physician for erythema and wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following month. Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy loss (UPRL) and healthy groups. Following achievement of the significant differences between both groups the immune profile of the healthy and UPRL subjects will be investigated.

NCT ID: NCT00602160 Recruiting - Food Allergy Clinical Trials

Therapeutic Effect of Chinese Herbal Medicine on Food Allergy

FAHF-2
Start date: December 2007
Phase: Phase 2
Study type: Interventional

The increasing prevalence of allergic diseases in westernized countries poses a significant health problem and a tremendous burden on quality of life and healthcare expenditure. Food allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Based on our preliminary studies, we hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergy. We are enrolling those age 12-45 yrs old with allergies to peanut, tree nuts, sesame, fish, and/or shellfish.

NCT ID: NCT00312312 Recruiting - Allergic Rhinitis Clinical Trials

Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide

Start date: March 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.

NCT ID: NCT00298376 Recruiting - Cow’s Milk Allergy Clinical Trials

Oral Tolerance in Cow’s Milk Allergy in the Infant

Start date: March 2006
Phase: N/A
Study type: Observational

This study aims to determine if there is a link between cow’s milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others. Cow’s milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge. Number and function of regulatory T cells and microflora composition are measured at the same time. Allergic infants are compared to age matched control group.

NCT ID: NCT00243555 Recruiting - Clinical trials for Peanut Hypersensitivity

Development of an Algorithm to Better Predict Clinical Responsiveness to Peanut

Start date: September 2002
Phase: N/A
Study type: Observational

The purpose of this study is to develop a tool to better predict clinical allergy to peanut, so that those who are skin test positive but non allergic will not have to unnecessarily avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion challenge, and treated appropriately