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Hypersensitivity clinical trials

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NCT ID: NCT02158026 Recruiting - Subfertility Clinical Trials

Evaluation of the Role of Follicular Sensitivity Index in the Prediction of Pregnancy in Women Undergoing ICSI/IVF Without Polycystic Ovarian Syndrome

Start date: June 2014
Phase: N/A
Study type: Observational

1000 women with infertility who are already decided to be treated with ICSI will be subjected to full history taking and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm. All patients will have standard pituitary down-regulation followed by (Human menopausal gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is defined as number of follicles measuring≥16mm. Follicular sensitivity index (FSI) will be calculated as: (FSI =PFC*10000/AFC*Total dose of FSH)

NCT ID: NCT02149134 Recruiting - Cow's Milk Allergy Clinical Trials

Evaluation of the Efficacy of a New Infant Formula in Subjects With Cow's Milk Allergy

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's milk protein allergy prevalence is often due to differences in study populations, study design and a lack of defined diagnostic criteria. The importance of defined diagnostic criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids delay in diagnosis, which can lead to malnutrition. There are two clinical types of cow's milk protein allergy: the immediate and the delayed type. The immediate type usually presents within minutes after the ingestion of cow's milk protein with urticaria, angio-oedema, vomiting or an acute flare of atopic dermatitis and is present in slightly more than half of the patients with cow's milk protein allergy. Delayed reactions such as atopic dermatitis or gastrointestinal symptoms like proctocolitis or enteropathy usually present after hours or days. Immunologically, cow's milk protein allergy can be IgE or non-IgE mediated. IgE mediated reactions are often of the immediate type. Non-IgE mediated reactions are often cell mediated or mixed cell and IgE mediated and are more difficult to prove by specific testing. The immunological reaction differentiates cow's milk protein allergy from other milk induced pathology such as lactose intolerance. A variety of symptoms can be suggestive for cow's milk protein allergy although none of them is diagnostic. A good medical history remains the cornerstone for the diagnosis. The treatment of cow's milk protein allergy is the dietary elimination of cow's milk proteins. In non-breastfed infants and children less than 2 years of age, a substitute formula is mandatory as prescribed by several international scientific societies. Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is often a whey or casein based formula in which the protein has been chopped up in smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant should be maintained on an elimination diet until the child is between 9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms will improve substantially within 2-4 weeks if diagnosis is correct. According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants. The aim of the investigators study is to show the efficacy, tolerance and nutritional adequacy of a newly developed thickened extensively hydrolyzed formula in infants with a proven cow's milk protein allergy. In all included patients, cow's milk protein allergy will have been diagnosed based on a double blind placebo controlled food challenge, considered as golden standard in cow's milk protein allergy diagnosis. To evaluate efficacy of the formula, the formula has to be tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants following literature consensus. A symptom diary will be filled out for this purpose by the patients' parents or legal guardians and the patient will be followed clinically by his doctor several times during the study period. Nutritional adequacy of the formula will be evaluated clinically by following growth and weight several times during the study period and by comparing it to the standard WHO growth curves, based on breastfed infants.

NCT ID: NCT02144428 Recruiting - Cow's Milk Allergy Clinical Trials

Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy

Start date: April 2011
Phase: N/A
Study type: Observational

The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.

NCT ID: NCT02087930 Recruiting - Cow Milk Allergy Clinical Trials

Microbiota as Potential Target for Food Allergy

MATFA
Start date: March 2013
Phase:
Study type: Observational

Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.

NCT ID: NCT02062476 Recruiting - Cow's Milk Allergy Clinical Trials

Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy

Start date: July 2013
Phase: Phase 2
Study type: Interventional

Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic disorders. We have shown that Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk allergy (CMA). The mechanisms of these effects are still largely undefined. The effect of LGG could be related at least in part by the immunoregulatory role played by LGG. This probiotic can balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated CMA (i.e., IL-4, IL-5, IL-10, IFN-γ , TGF-beta, and TNF-alfa), which can contribute to modulation of inflammatory processes. We have demonstrated that children with IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's milk protein, and that tolerance is associated with a marked reduction of IL-13 production and a concomitant increased frequency of IFN-γ releasing cells. Epigenetics studies the heritable (and potentially reversible) changes of the genome inherited from one cell generation to the next which alter gene expression but do not involve changes in primary DNA sequences, highlighting the complexity of the inter-relationship between genetics and nutrition. There are three distinct, but closely interacting, epigenetic mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are responsible for modifying the expression of critical genes associated with physiologic and pathologic processes. The profile of epigenetic modifications associated with Th lineage commitment, coupled with the sensitivity of the early developmental period, has led to speculation that factors that disrupt these pathways may increase the risk of allergic diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour Th2-associated allergic differentiation. MicroRNAs are another structural components of an epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has been recently identified a specific Th2-associated miRNA (miR-21) that is critical for the regulation of Th cell polarization.

NCT ID: NCT02031120 Recruiting - Clinical trials for Drug Hypersensitivity

Management of Drug Hypersensitivity in Children

DHC
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.

NCT ID: NCT01972113 Recruiting - Obesity Clinical Trials

Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)

Start date: September 2013
Phase: N/A
Study type: Interventional

The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.

NCT ID: NCT01914029 Recruiting - Clinical trials for Allergy Desensitization

Immunological Mechanisms of Allergy Immunotherapy

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

The purpose of the study is to add to the knowledge of mechanisms of immune health. Parameters of the immune system will be followed over time in volunteers allergic to dust mites and bee sting after receiving immunization therapy. This information will be compared to healthy volunteers without allergy. We aim to bring new understanding of immune processes by this comparison.

NCT ID: NCT01809145 Recruiting - Sarcoidosis Clinical Trials

Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure.

NCT ID: NCT01776489 Recruiting - Food Allergy Clinical Trials

Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy

Start date: December 2011
Phase: N/A
Study type: Observational

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date. Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).