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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051991
Enrollment
100
Registered
2023-08-26
Start date
2023-08-28
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

Male/female adults

Interventions

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18 years or older and younger than 65 years. 2. Subjects with self-reported perennial allergic symptoms. 3. Subjects with a positive house dust or mite-specific IgE (Class 1 or higher). 4. Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: 1. Subjects who regularly use or have regularly used anti-allergy medications (including antihistamines, eye drops and nasal drops), excluding those who take or have taken them occasionally. 2. Subjects undergoing treatment for hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine, or metabolic conditions, or those with a significant medical history related to these conditions (except for appendectomy). 3. Subjects with a drug allergy or severe food allergy, or those with a history of such allergies. 4. Subjects who are pregnant, intend to become pregnant during the trial period, or are breastfeeding. 5. Subjects who have participated in other clinical trials for drugs or food within the past month, or plan to participate in another clinical trial after consenting to participate in this trial. 6. Subjects who donated blood or component (200 mL) within the last 1 months. 7. Subjects who donated his blood (400 mL) within the last 3 months. 8. Subjects who donated her blood (400 mL) within the last 4 months. 9. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research. 10. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this research. 11. Subjects deemed unsuitable to participate as per the judgment of the principal investigator or sub-investigator, based on the subject's background, physical findings, medical examination, and physiologic test results.

Design outcomes

Primary

MeasureTime frame
Nasal and ocular allergy self-reported symptom scores (symptom score, medication score, symptom-medication score)

Secondary

MeasureTime frame
Japanese rhinoconjunctivitis quality of life questionnaire

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

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