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Clinical Trials/JPRN-jRCTs031200075
JPRN-jRCTs031200075CompletedPhase 2

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

Sugiura Shiro0 sites10 target enrollmentStarted: August 1, 2020Last updated:

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
10

Study Overview

Brief Summary

In the case of children with severe cow's milk allergy, Kestose increased the total load in the cow's milk oral tolerance test. While the severity of cow's milk allergy may have improved to some extent, it may be necessary to combine Kestose with other treatments in order to obtain clear effects such as induction of desensitization. The increase in Faecalibacterium, before and after the study suggested that the effect was due to the improvement of the intestinal environment, but there was no significant cor

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 1age old to < 15age old (—)
Sex
All

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

  • 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)

Investigators

Sponsor
Sugiura Shiro

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