A study to verify the effects of 1-Kestose continuous intake for pediatric milk allergy patients

An open-label study exploring the effects on allergic response of continuous intake of 1-Kestose for children who have been diagnosed with milk allergy and have completely removed milk

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200075

Enrollment

Registered

2020-08-01

Start date

2020-08-01

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 allergy Milk allergy

Interventions

Oral intake of 1-Kestose 1 or 2g once a day for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who have been diagnosed with milk allergy in the milk oral challenge test and instructed complete removal of milk 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 under 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

Measure	Time frame
Results of oral food challenge test conducted at the beginning of the study and after 12 weeks from the start of intake	—

Secondary

Measure	Time frame
1)TARC amount, total IgE level, milk-specific IgE and IgG4 level, casein IgE, beta-lactoglobulin IgE, and alpha-lactalbumin IgE level in serum at the start of intake of 1-Kestose and after 12 weeks from the start of intake 2)EASI score at the start of intake of 1-Kestose and after 6 weeks and 12 weeks from the start of intake 3)Analyze IgA level and the intestinal flora in feces by using the next-generation sequencer at the start of intake of 1-Kestose and after 6 weeks and 12 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.	—

Measure

Time frame

1)TARC amount, total IgE level, milk-specific IgE and IgG4 level, casein IgE, beta-lactoglobulin IgE, and alpha-lactalbumin IgE level in serum at the start of intake of 1-Kestose and after 12 weeks from the start of intake 2)EASI score at the start of intake of 1-Kestose and after 6 weeks and 12 weeks from the start of intake 3)Analyze IgA level and the intestinal flora in feces by using the next-generation sequencer at the start of intake of 1-Kestose and after 6 weeks and 12 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 ContactShirou 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