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Milk Hypersensitivity clinical trials

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NCT ID: NCT05883384 Recruiting - Cow's Milk Allergy Clinical Trials

Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy

Start date: January 1, 2023
Phase:
Study type: Observational

Cow's milk protein allergy is a sensitivity reaction against cow's milk protein and and is calcified as IgE-medaited, non- IgE mediated and mixed type according to the underlying immunological mechanism. Cow's Milk related Symptom Score ( CoMiSS) Considers general manifestation and dermatological, gastrointestinal and respiratory symptoms.

NCT ID: NCT05785299 Recruiting - Food Allergy Clinical Trials

Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy

ENIGMA
Start date: October 10, 2023
Phase: N/A
Study type: Interventional

There are a lot of parents who believe that their child may not tolerate cow's milk because they develop symptoms such as redness of the skin or they may vomit. It is not always easy to find out if these infants should indeed avoid drinking cow's milk or that the symptoms are caused by something else, for instance because they have a viral illness. The goal of the investigators is to find out if cow's milk should be introduced in the hospital or if it can also be advised to perform the introduction at home to determine if an infant can drink cow's milk without developing symptoms. Half of the participants will drink cow's milk in the hospital. This test is performed on two days. On one of the days cow's milk will be offered. On the other day a look-alike substance is offered. The other half of the participants will drink cow's milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cow's milk. The main question is whether both tests can be used to find out if an infant can drink cow's milk without developing symptoms.

NCT ID: NCT05731206 Suspended - Cow's Milk Allergy Clinical Trials

Hypoallergenicity of a Hydrolyzed Protein Infant Formula

HYPO STORY
Start date: March 31, 2024
Phase: N/A
Study type: Interventional

Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

NCT ID: NCT05618704 Recruiting - Cow Milk Allergy Clinical Trials

Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

STORY
Start date: March 16, 2023
Phase: N/A
Study type: Interventional

This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein formula.

NCT ID: NCT05503446 Recruiting - Peanut Allergy Clinical Trials

Using Commonly Available Food Products To Treat Food Allergy

NATASHA
Start date: January 19, 2023
Phase: N/A
Study type: Interventional

Food allergy affects 1 in 30 children, and is the commonest trigger for life-threatening reactions (anaphylaxis) in this age group. It is a major public health issue, with practical implications for industry, education and healthcare systems. Oral immunotherapy (OIT) is an emerging treatment option, where small, increasing doses of a food allergen are used to cause "desensitisation", so food-allergic individuals no longer have symptoms when exposed to the trigger food. However, frequent allergic reactions during OIT (including anaphylaxis) are common, and can lead to patients having to stop treatment. In addition, food-allergic children usually dislike the taste of the food they are allergic too, which affects compliance and treatment success. There is a lack of longer-term data to inform cost-effectiveness analyses for OIT. The NATASHA study will recruit young people from age 6+ years with IgE-mediated peanut allergy, and young people aged 3+ years with IgE-mediated allergy to cow's milk, who will undergo oral immunotherapy for these allergens using real-world foods (taken carefully according to a standardised protocol under medical supervision). In addition to assessing efficacy and safety outcomes, we will also collect longer-term data to evaluate cost-effectiveness in the UK setting.

NCT ID: NCT05406141 Recruiting - Cow Milk Allergy Clinical Trials

Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

The main purpose of this study is to evaluate efficacy and safety of an amino acid-based formula Neocate Jr in children with food protein allergy, and to evaluate nutrition sufficiency of Neocate Jr in 1 to 10 years old children with food protein allergy.

NCT ID: NCT05309772 Recruiting - Food Allergy Clinical Trials

The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy

Start date: January 13, 2023
Phase: N/A
Study type: Interventional

The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. an oral food challenge in case of equivocal SPT/sIgE) or follow a basophil activation test (BAT)/mast cell activation test (MAT)-based strategy, i.e. patients with a positive BAT or MAT are dispensed of an oral food challenge (OFC) and patients with a negative BAT/MAT undergo an OFC.

NCT ID: NCT05293353 Recruiting - Preterm Clinical Trials

Neokare Safety and Tolerability Assessment in Neonates With GI Problems

Start date: June 9, 2022
Phase:
Study type: Observational

With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP containing feed in high risk babies. Delivery of adequate nutritional intake is one of the great challenges in the care of newborn infants, particularly those born preterm or with gastrointestinal problems. Whilst there are recognised benefits of human milk, a diet of exclusive human milk may not meet the nutritional demands of the infant. To close this gap, breast milk fortifier (BMF) is typically added to human milk. However, addition of BMF may be associated with gastrointestinal disturbance, possibly due to the fact that it contains CMP. This research study is to test the tolerability and safety of a new human milk-based BMF in neonates with gastrointestinal problems. It is hoped that this may provide an opportunity for high risk infants, to receive the benefits of human milk whilst minimising the risks reported to be associated with CMP. Eligible infants will be those in whom nutritional supplementation of breast is deemed clinically necessary, a weight of greater than 1.0kg at the time of starting fortifier and at least one of: - previous gastrointestinal surgery - congenital gastrointestinal anomaly - medically treated gastrointestinal disease - previously suspected intolerance of CMP based breast milk fortifier in the absence of other gastrointestinal disease Infants will be started on human milk-based BMF once they are tolerating 100 mls per kilo per day of human breast milk. The human milk-based fortifier will be commenced at half the recommended dose for 48 hours then increase to full strength. This will be continued until the infant reaches 44 weeks corrected gestational age, or until such time as they are deemed to no longer require the additional nutrition.

NCT ID: NCT05178004 Recruiting - Cow Milk Allergy Clinical Trials

Microbiome and Immune Profiling in Infant With Cow's Milk Allergy

Start date: August 1, 2018
Phase:
Study type: Observational [Patient Registry]

Non-IgE-mediated cow's milk allergy (CMPA) is associated to gastrointestinal symptoms, and its cause remains poorly understood, limiting the identification of specific markers to help with the diagnosis. Using a non-invasive method, the aim of this study is to identify new protein markers as well as to profile the bacteria (germs) released in stools of infants during the inflammatory process of this condition (acute and recovery phase). The study group will include infants who are born at term by an uncomplicated birth and diagnosed with non-IgE-mediated CMPA in the first 4 months of life, while the control groups will consist of infants either healthy or infants diagnosed with IgE-mediated CMPA or with a non-allergic gastrointestinal inflammatory condition (NAGIC). All groups will be matched for age, gender, type of feeding and mode of delivery. Stool, urine and blood samples (the latter only if already taken during the hospital admission in severe cases) will be collected at the acute and the recovery phase of this condition while the patient follows a diary free diet (breast milk or hypoallergenic formula milk). Protein markers, bacteria and their products will be measured in stool, urine and blood samples. These measurements will be carried out at the University of Glasgow, Human Nutrition Section labs at Glasgow Royal Infirmary and other University of Glasgow research labs as required. The ultimate aim is to explore the potential role of immune protein markers and bacteria in stools and urine and their possible use in diagnosing the condition non-invasively. Further understanding of the disease's cause may contribute to the development of new infant feed that could provide gut protection.

NCT ID: NCT05121753 Recruiting - Clinical trials for Necrotizing Enterocolitis

Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

Start date: February 15, 2022
Phase:
Study type: Observational

Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality. Early diagnosis and early treatment interventions may reduce the risk of mortality and morbidity. The Primary goal of this observational study is to gather survey data to establish a national database of NEC in newborns in order to better understand the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.