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A study to evaluate the efficacy of 1-Kestose supplementation for pediatric milk or egg allergy infants and children.

A Randomized, placebo-controlled, double-blind, parallel-group comparison the efficacy of 1-kestose supplementation on allergic response in infants and children who have been diagnosed with milk or egg allergy.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250854
Enrollment
60
Registered
2026-03-27
Start date
2026-03-27
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

Milk or hens egg allergy Milk allergy, Egg allergy

Interventions

Oral intake of 1-Kestose 1 or 2g once a day for 24 weeks

Sponsors

Sugiura Shiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Infants and children who have been diagnosed with milk or egg allergy in the oral food challenge. 2)Persons who can obtain the consent of parents who fully understand the purpose and content of this test. As much as possible, obtain verbal or written ascents from the research subject. 3)Persons who are between 6 months and 15 years old Japanese at the time of informed consent.

Exclusion criteria

Exclusion criteria: 1)Persons who have chronic illness, receiving medication, have a serious disease history except allergic diseases 2)Persons who are allergic to the test food 3)Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 4)Persons who ingest probiotic food and prebiotic food on a daily basis (more than 3 times a week)

Design outcomes

Primary

MeasureTime frame
Results of oral food challenge test conducted at the beginning of the study and after 12 weeks and 24 weeks from the start of intake

Secondary

MeasureTime frame
1)Milk- or egg-white-specific IgE and IgG4 levels in serum at the start of intake of 1-Kestose and after 12 weeks and 24 weeks from the start of intake 2)EASI score at the start of intake of 1-Kestose and after 6, 12, 18, and 24 weeks from the start of intake 3)Analyze the intestinal flora in feces using the next-generation sequencer at the start of intake of 1-Kestose and after 12 weeks and 24 weeks from the start of intake. 4)Confirm the presence or absence of adverse events during the study period through daily diaries and medical interviews.

Contacts

Public ContactShiro Sugiura

Aichi Children's Health and Medical Center

shirou_sugiura@sk00106.achmc.pref.aichi.jp+81-562-43-0500

Outcome results

None listed

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