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Food Allergy clinical trials

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NCT ID: NCT06452381 Active, not recruiting - Food Allergy Clinical Trials

Allergenicity Assessment of Green Marine Macroalga Ulva sp.

Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

To determine the allergenic potential in humans, we will conduct a three-stage clinical trial. In the first group, 20 healthy volunteers will be involved. All volunteers will be examined by an allergy specialist before enrolment to the study. After receiving informed consent, all volunteers will undergo an allergy skin test to the study seaweed proteins as well as to common allergens. Participants with a skin test showing sensitization will be excluded. Volunteers will be fed by 5 gram of the study seaweed 2 times a week, under supervision, for 6 weeks. After 6 weeks of feeding, skin tests will be repeated. All participants, will undergo an open oral food challenge after one month of avoidance of the study seaweed protein. Uneventful food challenge will rule out food allergy in a specific volunteer. Second, the extension clinical phase will be conducted with 100 healthy volunteers. The inclusion, exclusion and study design will be similar to the pilot study. The third phase will be conducted in a group of high-risk patients aimed to find the frequency of allergy to the study seaweed in high risk patients. Study population: 20 volunteers with high risk to seaweed food allergy. Inclusion criteria: Adults (>18 years old, males and females) with at least one of the following: Active atopic dermatitis or fish or sea food allergy. Study design will be similar to the pilot study.

NCT ID: NCT04887441 Active, not recruiting - Food Allergy Clinical Trials

Allergology: Information, Data and Knowledge Organization

ALLERGIDOC
Start date: September 1, 2019
Phase:
Study type: Observational

Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work. In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.

NCT ID: NCT04249973 Active, not recruiting - Food Allergy Clinical Trials

Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children

Start date: January 26, 2018
Phase:
Study type: Observational [Patient Registry]

In this study, fecal and urine samples will be collected from children diagnosed with : - IgE mediated cow's milk allergy, - suspected of a cow's milk allergy, but with negative diagnosis - IgE mediated food allergy other than cow's milk - healthy brothers and sisters of the first three groups A subset of patients with IgE-mediated cow's milk allergy will be asked to provide a urine and fecal sample yearly for prognostic purposes. The samples will be analyzed using a technique called metabolomics to identify biomarker candidates with diagnostic and/or prognostic potential. Additionally, microbiome analysis will be performed to map the microbiome of all groups.

NCT ID: NCT03799328 Active, not recruiting - Food Allergy Clinical Trials

Low Dose Multi-OIT for Food Allergy (LoMo)

LoMO
Start date: May 23, 2019
Phase: Phase 2
Study type: Interventional

Oral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies. Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects. The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and

NCT ID: NCT03744325 Active, not recruiting - Food Allergy Clinical Trials

Immune Responses in Hen's Egg Oral Immunotherapy

Start date: March 18, 2014
Phase: N/A
Study type: Interventional

The study determines how a 6 months oral immunotherapy (OIT) program with hen's egg (HE) effects cellular and humoral immune responses in 50 children with HE allergy. Clinical data, transcriptomics and epigenetics are combined and analyzed by advanced system biology methods. This study will provide better understanding of the effects and mechanisms of OIT.

NCT ID: NCT02879006 Active, not recruiting - Food Allergy Clinical Trials

E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy

Start date: August 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to foods be able to safely tolerate food allergens. Specifically in this protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame, and/or wheat. Omalizumab is considered an investigational drug for the treatment of food allergies in children and adults. Investigational means it has not been approved by the Food and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained unresponsiveness (which is the ability to consume a food allergen and pass an oral food challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be able to safely ingest the foods they are allergic to.

NCT ID: NCT02112734 Active, not recruiting - Food Allergy Clinical Trials

Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2

VITALITY
Start date: December 2014
Phase: Phase 4
Study type: Interventional

We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.

NCT ID: NCT01779180 Active, not recruiting - Asthma Clinical Trials

Vitamin A Supplementation at Birth and Atopy in Childhood

Start date: January 2013
Phase: N/A
Study type: Observational

INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation (NVAS) have been reported, and another four are underway to test whether NVAS should become WHO policy. Three of the four African trials were conducted by the Bandim Health Project (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In 2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of NVAS on atopy and wheezing was found (manuscript under review). Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS is associated with a higher risk of atopy and wheezing. The investigators therefore aim to conduct a similar follow-up study of participants in the first NVAS trial conducted in Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is associated with an increased risk of atopy and wheezing and other allergic symptoms as well as growth. METHODS Study population: From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns when they came for BCG vaccination. Provided parental consent, they received an oral supplement of 50,000 IU vitamin A or placebo. Study design: This study will be a follow-up study of the cohort of children randomised to NVAS (intervention) or placebo (current policy) together with BCG vaccine at birth. Other exposures: The investigators will also investigate the effect of receiving an additional dose of measles vaccine and the timing of DTP vaccine on the development of atopy. Assessment of outcomes: The investigators will visit all children at the last known address. Height, weight and mid upper arm circumference will be measured. BCG scar will be examined and vaccination card details recorded by the field assistant. Children will be excluded from skin prick testing (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine medication. SPT will be performed using aero-allergens, food allergens and positive histamine and negative saline control. The mother or guardian will be interviewed by a local assistant. Symptoms of eczema and asthma as well as food allergy will be assessed. Statistical analysis: Effect of randomisation group and other factors on outcomes will be analysed in multivariable regression models. All analyses will be adjusted for skin prick tester. All analyses will be conducted stratified by sex.

NCT ID: NCT01498965 Active, not recruiting - Obesity Clinical Trials

The Cork BASELINE Birth Cohort Study

BASELINE
Start date: August 2008
Phase: N/A
Study type: Observational

The Departments of Paediatrics and Child Health, Obstetrics/Gynaecology and Nutritional Sciences, University College Cork, and the Department of Dermatology, Trinity College, Dublin have a unique and urgent opportunity to form a birth cohort of over 2000 children whose growth and maternal health status will have been closely monitored from early pregnancy. Longitudinal monitoring of these infants will allow direct investigation of several research areas in a way which has not previously been possible in Ireland, or abroad. The investigators propose to focus on three main research themes: the effects of intrauterine growth restriction, the incidence and prevalence of food allergy and eczema in early childhood and the incidence and effects of maternal and infant vitamin D status on the growth and health of Irish children. Although the investigators initial proposal will focus on these important areas, the formation of this birth cohort will offer many opportunities for further research as the cohort grows older. It will form a unique bio-bank of information from Irish children collected longitudinally from soon after their conception. The mothers of these infants are currently being recruited, which leaves us with a narrow window of opportunity to put in place a pathway of investigation for these children. To ignore this opportunity would be to lose access to a wealth of information regarding child health and disease. The potential for this cohort to provide definitive answers to current, and future, theories of disease causation is enormous.