NCT05005611

Brief Summary

Probiotics, a component that is generally referred to as a living microorganism or a microorganism present in a host. Most studies have shown that probiotics can regulate immune function in the body. Many studies have attempted to understand whether the use of probiotics can prevent allergic diseases or not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

August 10, 2021

Last Update Submit

July 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skin severity scoring

    According to the scale to estimate skin severity

    3 months

Secondary Outcomes (3)

  • Blood analysis

    3 months

  • NGS in gastrointestinal tract

    3 months

  • Life quality

    3 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Probiotics Lactobacillus salivarius AP-32

EXPERIMENTAL
Dietary Supplement: Probiotics Lactobacillus salivarius AP-32

Probiotics Bifidobacterium animalis subsp. lactis CP-9

EXPERIMENTAL
Dietary Supplement: Probiotics Bifidobacterium animalis subsp. lactis CP-9

Probiotics Lactobacillus rhamnosus LGG

EXPERIMENTAL
Dietary Supplement: Probiotics Lactobacillus rhamnosus LGG

Interventions

PlaceboDIETARY_SUPPLEMENT

A pack of powder without probiotics. 1 pack / day

Placebo

A pack of powder with probiotics Lactobacillus salivarius AP-32 1 pack / day

Probiotics Lactobacillus salivarius AP-32

A pack of powder with probiotics Bifidobacterium animalis subsp. lactis CP-9 1 pack / day

Probiotics Bifidobacterium animalis subsp. lactis CP-9

A pack of powder with probiotics Lactobacillus rhamnosus LGG 1 pack / day

Probiotics Lactobacillus rhamnosus LGG

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Estimated by PI.

You may not qualify if:

  • Be allergic to medicine
  • Take medicine like immune inhibition, or steroid injection in two weeks
  • Participate in another clinical research or immune therapy in one month
  • Have severe disease
  • Inappropriate for this trial judged by PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Skin Care in children.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 13, 2021

Study Start

May 31, 2021

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations