A double-blind, randomized, parallel, placebo-controlled study to evaluate the efficacy and safety of a probiotic containing Lactobacillus paracasei (eN-Lac®) for the treatment of children with perennial allergic rhinitis (year-round nose irritation caused by allergy)

Not Applicable

Completed

• Conditions: Perennial allergic rhinitis (PAR); Ear, Nose and Throat

• Registration Number: ISRCTN14829274
• Lead Sponsor: GenMont Biotech (Taiwan)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36899903/ (added 09/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-07-12
• Study Start: 2022-10-28
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

1. Subjects with age of 5-16 years old (inclusive)
2. Subjects with a history of PAR for at least 1 year
3. Subjects with either one of the following test results (test results within 12 months before study are acceptable)
3.1. Positive skin-prick test reaction (wheal ?3mm larger than the diluents control)
3.2. Positive reaction determined by the CAP or MAST(Multiple allergosorbent test) system
4. Subjects with mean NTSS of no less than 5 throughout the screening period (4 to 10 days); at least 4 days should be recorded during the screening period; and the NTSS of the day before day-0 (first dosing day) visit is no less than 5
5. Subjects’ parents or their legally acceptable representatives have signed the written informed consent form

Exclusion Criteria

1. Subjects have clinically significant abnormalities laboratory results as determined by the investigator (Tests performed during 14 days prior to Visit 1 or during baseline period can be used for evaluating this criterion)
2. Subjects with acute or significant chronic sinusitis, severe persistant asthma, congenital immunodeficiency, neuropsychiatric disorders, immune-compromised massive wound in the oral cavity, use of rhinitis medications, and chronic use of tricyclic antidepressants
3. Subjects who need to take prohibited medications during the study or took the medications within 30 days prior to the screening visit:
- Parenteral or oral corticosteroids
- Nasal corticosteroids
- Topical use of flurandrenolide
- Topical use of clobetasol propionate
- Topical use of halobetasol propionate
- Astemizole
- Ketotifene
- Nedocromil or Sodium cromoglycate
- Loratadine
- Cetirizine
- Antileukotrienes
- Other H1 antihistamine
- Nasal decongestant
- Any food supplements including LP(Lactobacillus paracasei)
4. Subject is undergoing desensitization therapy within 3 months prior to the screening visit or with vasomotor rhinitis
5. Subject participated investigational drug trial within 4 weeks before entering this study
6. Patients are pregnant or lactating or plans to become pregnant
7. Subjects with any other serious disease considered by the investigator not in the condition to enter the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified