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Randomized double-blind comparative study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.

Randomized double-blind comparative study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children. - Study on the effect of bifidobacterial on the low dose oral immunotherapy for egg allergy children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033739
Enrollment
68
Registered
2018-08-15
Start date
2018-02-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hen&#39

Interventions

Bifidobacteria, twice a day, 42 weeks Dextrin, twice a day, 42 weeks

Sponsors

Showa University, Department of pediatrics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Obvious hen's egg allergic patients b) Patients who are 2 years or older and 5 years or younger at the start of the study c) After receiving sufficient explanation for the participation of this study, patients who obtained document consent with the free will of the patient himself or substitute person with sufficient understanding

Exclusion criteria

Exclusion criteria: a) Of control poor atopic dermatitis or bronchial asthma b) Cardiovascular, cranial nerve, Renal urology, Hepatobiliary, pancreatic, gastrointestinal, etc, which are serious or have diseases which may affect research c) Implementing other immunotherapy d) Other test responsibilities(shared) patients judged inappropriate by the doctor as subjects

Design outcomes

Primary

MeasureTime frame
The rate of 1/8 hen's egg tolerance at 32 weeks after intervention started

Secondary

MeasureTime frame
The rate of 1/32 hen's egg desensitization at 32 weeks after intervention started. Objective indicater(blood:change in eosinophil count,total IgE,antien specific IgE(egg white,egg yolk,ovomucoid),antigen specific IgG4(egg white,ovomucoid),basophil stimulation test(OVM), faeces:intestinal flora, calprotectin,skin prick test) Side reaction rate on oral immunotherapy, Safety assessment(incidence of adverse events)

Countries

Japan

Contacts

Public ContactMayu Maeda

Showa University Department of Pediatrics

mayu-shimi@med.showa-u.ac.jp0337848000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026