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Probiotics combined with oral Immunotherapy for patients with severe egg
allergy: A multicenter, randomized, double-blind, placebo-controlled clinical trial

Egg oral immunotherapy with probiotics for severe egg allergy (EPRO trial)

Nagakura Ken-Ichi

National Hospital Organization Sagamihara National Hospital

18-1 Sakuradai, Minami-ward, Sagamihara city, Ka nagawa pref., Japan

k.nagakura@foodallergy.jp

Nagakura Ken-Ichi

National Hospital Organization Sagamihara Nation al Hospital

18-1 Sakuradai, Minami-ward, Sagamihara city, Ka nagawa pref., Japan

+81-42-742-8311

k.nagakura@foodallergy.jp

Recruiting

Nov. 01, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

(1) Patients between 5 and 18 years of age
(2) Patients whose obvious immediate-type allergic symptoms were induced by less than 1/8 of a heated whole egg (775 mg of egg protein) in oral food challenge
(3) Patients whose consent to participate in this study has been obtained

(1)Patients with poorly controlled bronchial asthma(C-ACT or ACT 19 points or lower)
(2)Patients with poorly controlled atopic dermatitis(EASI 16 points or higher)
(3)Patients receiving other immunotherapies at the study entry. However, patients who have been on Japanese cedar or house dust mite SLIT or SCIT for at least 1 year and are stable without adverse reactions may be treated at the discretion of the attending physician.
(4) Patients on biological agents at the study entry.
(5) Patients using systemic steroids or immunosup pressive drugs at the study entry.
(6) Patients with diseases affecting the immune system (autoimmune diseases, immune complex diseases, immunodeficiency diseases, etc.)
(7) Patients using antibiotics within 1 month of study entry
(8) Patients whose physician determines that it is difficult to perform the study

Both

food allergy

This study is a double-blind, placebo-controlled, randomized, controlled trial.The study drug (probiotics or placebo) is 1 g once daily for 1 year. The study drug for probiotics contains 0.03 g of LGG (bacteria count: 1 x 10^9), 0.3 g of Bifidobacterium bifidum TMC3115 (bacteria count: 1 x 10^9), and an excipient (maltodextrin) in 1 g.
The protocol for oral immunotherapy with heated hen's egg powder is similar for both groups.

Food Hypersensitivity

D005512

Percentage of the patients who acquired tolerance for 1/2 a heated whole egg after 12 months from start of oral immunotherapy.

Percentage of the patients who acquired desensitization to 1/8 of a heated whole egg after 12 months from start of oral immunotherapy.
Frequency of adverse reactions during 12 months.
Rates of changing egg white/ovomucoid-specific IgE, IgG, and IgG4 levels during 12 months.
Number of infections with fever or requiring hospitalization during 12 months.
Diversity of the intestinal microbiota and change in bacterial species by 16S rRNA analysis.
Rates of changing in serum short-chain fatty acids during 12 months.

+81-52-951-1111

Sept. 14, 2022

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