One-Step Open Feeding for Eczema, Infantile

Phase-Based Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Eczema, Infantile+6 More
Eligibility
< 65
All Sexes
Eligible conditions
Eczema, Infantile

Study Summary

Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis

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Eligible Conditions

  • Eczema, Infantile
  • Dermatitis, Atopic
  • Dermatitis
  • Eczema
  • Peanut Hypersensitivity
  • Food Hypersensitivity
  • Hypersensitivity
  • Milk and/or Peanut Allergy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether One-Step Open Feeding will improve 1 primary outcome and 1 secondary outcome in patients with Eczema, Infantile. Measurement will happen over the course of Oral Food Challenge Visits.

Oral Food Challenge Visits
Allergy to milk and peanut status; allowing for estimation of IgE thresholds that determine a subgroup with at least 50% chance of tolerance in patients with elevated total serum IgE levels and history of AD.
Oral Food Challenge Visitsv
Basophil and mast cell reactivity and other exploratory markers.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

4 Treatment Groups

No Control Group
One-Step Open Feeding
Placebo group

This trial requires 200 total participants across 4 different treatment groups

This trial involves 4 different treatments. One-Step Open Feeding is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

One-Step Open FeedingParticipants who are consuming baked milk, straight milk, and/or peanut products at least once per week will do a one-step oral food challenge.
Milk DBPCFCThere are two double blind placebo controlled food challenges. The first challenge is to baked milk. The following participants will undergo this DBPCFC: -All participants who eat baked milk less than once per month. -Participants who never eat baked milk or straight milk. .On the first day of this challenge, participants will be randomized to either milk Baked milk or rice milk. Dry milk powder or corn starch. or placebo, and then will be challenged with the other food on the next day.
Two-Step Open FeedingParticipants who consume baked milk, straight milk, and/or peanut products less than once per week but at least once per month will do a two step open oral food challenge.
Peanut DBPCFC
Other
The DBPCFC for peanut allergy will be done with either peanut flour or a placebo (oat flour). The following participants will undergo this DBPCFC: -All participants who eat peanut less than once per month -Participants who never eat peanut. never eat peanut On the first day of this challenge, participants will be randomized to either peanut or placebo, and then will be challenged with the other food on the next day.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: oral food challenge visitsv
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly oral food challenge visitsv for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Aged 3-21 years.
Currently enrolled on study 15-I-0162, Natural History and Genetics of Food Allergy and Related Conditions.
Has a total serum IgE level greater than or equal to 1000 kU/L at time of screening.
Has a history of AD based on self-report or physician assessment.
Willing to undergo an oral food challenge to both placebo and test food.
Willing to allow storage of blood samples for future use in medical research.
Willing to allow genetic testing to be conducted on blood samples.
Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives.
Be willing to discontinue omalizumab or dupilumab within 6 months of a food challenge,and antihistamines and oral steroids prior to a food challenge, as these drugs might interfere with the oral food challenge procedure. Use of topical steroids will be allowed
Able to provide informed consent.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get eczema, infantile a year in the United States?

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The prevalence and incidence of eczema are underestimated because of the difficulty in ascertaining the diagnosis for patients with the condition. For example, if a parent reports that their child has eczema, a health care provider may be reluctant to make a formal diagnosis. While the prevalence of eczema is 0.2% in industrialized countries, it apparently ranges from about 0.5% to over 1% among the children of indigenous people of the Americas. If eczema was a disease of affluence and not a skin disease affecting some lower socioeconomic segments of the population, more than 2 million U.S. adults would be affected by it annually. The incidence of eczema is about 1 case per 1000 population.

Unverified Answer

Can eczema, infantile be cured?

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Results from a recent clinical trial, topical or systemic antibiotics have not provided any advantage over control in this study. Moreover, some recent studies have shown that, in infants under 7 years of age, eczema is not a temporary condition. Therefore, a short term antibiotic treatment is not helpful in this condition.

Unverified Answer

What are common treatments for eczema, infantile?

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Frequent use of topical corticosteroids and corticotherapies may be effective treatments for eczema, infantile, and may be particularly effective in the treatment of infants. The benefits of systemic corticosteroids are still controversial and not fully established; they are not routinely recommended. The optimal choice for patients with eczema, infantile, or atopic dermatitis, however, can be difficult and is often debated. The combination of short- to medium-term topical corticosteroids with systemic corticosteroids and/or nonsystemic corticosteroids may reduce the need for long-term systemic corticosteroids, reduce side effects, and reduce drug interaction problems.

Unverified Answer

What are the signs of eczema, infantile?

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Eczema, infantile affects at least half of the infants with recurrent respiratory infections and may be part of a complicated interplay involving multiple environmental factors. We found that the clinical impression of a parent was predictive of children with eczema, even after adjusting for multiple potential correlates. We suggest that the clinical impression of a parent may be one of the earliest clinical signs that may suggest the presence of eczema.

Unverified Answer

What is eczema, infantile?

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Eczema and atopic dermatitis are related, however, with the exception of the mild form, eczema is the predominant form. About 12% of children in the USA had an eczematous disease diagnosis. Eczema is typically present in infancy.

Unverified Answer

What causes eczema, infantile?

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The cause of eczema, infantile is mainly due to a genetic component with environmental factors only very small. The use of antibiotics has to be regarded as an essential factor both in utero and early childhood which is in combination with a family background predisposing for eczema.

Unverified Answer

Have there been other clinical trials involving one-step open feeding?

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In spite of the improvement in care, there have still been few studies regarding one-step open feeding. Although the results of the aforementioned studies have been encouraging, the long-term benefits of one-step feeding still unknown. Nevertheless, there are still many clinicians who advocate for utilizing one-step open feeding therapy.

Unverified Answer

Who should consider clinical trials for eczema, infantile?

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This article outlines several important information about eczema research. It introduces the concept of eczema subtyping (IgE-dependent and non-IgE-dependent) and discusses several clinical trials examining various types of eczema. Further, in the [Appendix], the authors provide evidence that eczema might be a good indication to test for familial predisposition to allergic diseases.

Unverified Answer

Does one-step open feeding improve quality of life for those with eczema, infantile?

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A 1-step open approach to infant feeding was effective in improving the quality of life across multiple areas of health, as well as reducing the amount of time taken to feed babies at the hospital.

Unverified Answer

How does one-step open feeding work?

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Data from a recent study shows that open bottle can be implemented successfully by trained nurses, as long as adequate support is provided, irrespective of patient-to-patient variability.

Unverified Answer

What is the latest research for eczema, infantile?

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Eczema is an inflammatory skin disease that commonly follows a pattern of skin irritations, which lead to the abnormal proliferation of the skin and underlying layer, namely the dermis. Dermatological research demonstrates the possibility of using the same anti-eczema target as a potential treatment strategy for other autoimmune conditions such as Crohn's disease. In addition, the most recent research showed that infantile eczema can be treated by oral and inhaled glucocorticosteroids that effectively reduce or remit disease flares and/or improve the patient-reported symptoms of this condition.

Unverified Answer

What does one-step open feeding usually treat?

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(1) One-step open feeding can be an effective treatment of infantile eczema for infants aged 3–5 months. (2) The time-to-nonsnoring interval is shorter when the infant is open fed. (3) We propose that two-step open feeding should be the first choice of treatment for infants with infantile eczema.

Unverified Answer
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