Unique ID issued by UMIN | UMIN000019671 |
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Receipt number | R000022727 |
Scientific Title | Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy. |
Date of disclosure of the study information | 2015/11/06 |
Last modified on | 2020/02/13 11:08:04 |
Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Study of diet for tolerance induction with food allergy children.
Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.
Japan |
Food allergy
(Hen's egg,cow's milk,wheat)
Pediatrics |
Others
NO
Comparison of efficacy between low dose ingestion of responsible food on alternate days and complete elimination therapy for children with food allergy.
Efficacy
Difference of threshold of tolerance dose after treatment between low dose ingestion of responsible food on alternate days and complete elimination for food allergy.
1)Desensitization of food allergy
2)The change of antigen-specific antibody IgE and IgG4 in serum,and result of skin prick test.
3)The change of quarity of life by questionnaire.
4)Incidence of bronchial asthma.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
Pseudo-randomization
2
Treatment
Food |
Low dose ingestion of responsible food(
a thirty-second of hen's egg for egg allergy,3ml of cow's milk for milk allergy,or 3g of Udon noodles for wheat allergy) on alternate days for 6 months.
Complete elimination therapy for 6 months.
Not applicable |
3 | years-old | > |
Male and Female
1)Patients with immediate allergic reactions to hen's egg,cow's milk or wheat.
2)Patients are confirmed obvious positive objective symptoms caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake and the titer of specific IgE is more than 95% positive predictive value at the probability curve.
3)The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a eighth of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 24ml,and that for wheat is more than 3g of Udon noodles and not greater than 24g of that.
1)The patients who cannot be obtained informed consent by themselves or their guardians.
2)The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg,3ml of cow's milk, or 3g of Udon noodles by oral food challenge test.
3)Patiens with a history of anaphylactic shock caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake.
4)The patiens with poorly controlled asthma or atopic dermatitis.
5)The patient who the attending physician determines inappropriate.
52
1st name | |
Middle name | |
Last name | Takanori Imai |
Showa university school of medicine
Department of pediatrics
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
03-3784-8000
ta-imai@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Mayu Shimizu |
Showa university school of medicine
Department of pediatrics
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
03-3784-8000
mayu-shimi@med.showa-u.ac.jp
Showa university school of medicine,Department of pediatrics
Grants-in-Aid for Scientific Reserch
Japan
NO
2015 | Year | 11 | Month | 06 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 30 | Day |
2014 | Year | 05 | Month | 26 | Day |
2014 | Year | 10 | Month | 16 | Day |
2018 | Year | 12 | Month | 31 | Day |
2015 | Year | 11 | Month | 06 | Day |
2020 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022727
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