Egg oral immunotherapy with probiotics for severe egg allergy

JRCT ID: jRCTs041220087

Registered date:01/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: food allergy
• Date of first enrollment: 16/01/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

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

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 18age old
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Nagakura Ken-Ichi
• Source(s) of Monetary Support: National Hospital Organization