Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis in Children

November 20, 2024 updated by: Wecare Probiotics Co., Ltd.

Effectiveness of Lacticaseibacillus Rhamnosus LRa05 in Alleviating Allergic Rhinitis and Its Impact on Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled Trial

The clinical trial aims to investigate the efficacy of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis and its impact on the gut microbiota among 70 pediatric participants aged 4-12. The primary objective is to validate the improvement in allergic rhinitis symptoms following an 8-week intervention with Lactobacillus rhamnosus LRa05. Participants were instructed to consume the probiotic powder daily for approximately 8 weeks. At baseline, week 4, and week 8 endpoints, assessments of nasal symptoms, quality of life questionnaires, and stool samples for microbiota analysis were conducted on the participants, and blood samples were collected for immune-related factor testing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research has indicated that allergic rhinitis (AR) is associated with a decrease in the diversity of the gut microbiota, particularly in children, potentially linking to the development of allergic diseases. Preclinical studies have shown that supplementation with Lactobacillus rhamnosus LRa05 can regulate immune responses, inhibit inflammatory factors, and the predictive functions of the gut microbiota suggest an increase in gene abundance within pathways related to immune modulation, anti-inflammatory effects, and maintenance of gut barrier integrity. To ascertain the effectiveness of the probiotic strain LRa05, a randomized, double-blind, placebo-controlled trial was conducted by the investigators to evaluate and gather data on alterations in the gut microbiota and allergic rhinitis symptoms among pediatric participants. The trial spanned over 8 weeks, with washout periods incorporated at the commencement and conclusion. Throughout the study, participants ingested Lactobacillus rhamnosus LRa05 and were subjected to a series of health examinations and assessments, including nasal symptom scores, quality of life questionnaires, and stool sample collections for microbiota analysis, as well as blood samples for immune-related factor testing. The primary objective was to validate the improvement in allergic rhinitis symptoms and the modulation of the gut microbiota following the intervention with LRa05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shangdong
      • Jinan, Shangdong, China, 250012
        • Qilu Hospital of Shangdong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study;
  2. Capable of completing the study according to the test protocol requirements;
  3. Age between 4 to 12 years old;
  4. Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised Edition 2022)";
  5. Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than one hour per day, possibly accompanied by eye itching, tearing, and redness, and other ocular symptoms;
  6. Signs: Nasal mucosa is pale and edematous, possibly with watery secretions;
  7. Laboratory tests: At least one allergen detected by skin prick test and/or specific IgE positivity in serum;
  8. No use of antihistamines, corticosteroids, or immunosuppressants in the month before screening;
  9. No history of heart, liver, kidney, nervous system, mental disorders, or metabolic abnormalities.

Exclusion Criteria:

  1. Use of medications affecting the gut microbiota (including antimicrobial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week within 1 month prior to screening;
  2. Patients with coexisting pulmonary tuberculosis;
  3. Those with coexisting allergic asthma;
  4. Individuals with nasal polyps or severe nasal septal deviation;
  5. Patients with severe systemic diseases or malignant tumors;
  6. Those with congenital genetic diseases or congenital immunodeficiency diseases;
  7. Regular use of probiotics or prebiotics within 6 months prior to the screening period;
  8. Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.);
  9. Those with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
  10. Individuals with sinusitis, otitis media, or respiratory tract infections;
  11. Those allergic to any components of the probiotics used in this trial;
  12. Women who are pregnant or breastfeeding, or those planning to conceive in the near future;
  13. Subjects who discontinue the test sample or add other medications midway, making it impossible to determine efficacy or with incomplete information;
  14. Those who have recently consumed items similar to the test product, affecting the judgment of the results;
  15. Subjects who, due to their own reasons, cannot participate in the trial;
  16. Any other subjects deemed unsuitable to participate by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
Participants in the placebo group received 3g of maltodextrin per day.
Dietary supplement: Maltodextrin
During the study, subjects in the control group take one sachet of maltodextrin daily with 3.0g. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the 8-week trial.
Experimental: Probiotic group
Participants in the probiotic group received 1 sachet probiotic product per day.
Dietary supplement: probiotic product
During the study, subjects take one sachet of Lactobacillus rhamnosus LRa05 daily. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Total Nasal Symptom Score (TNSS)
Time Frame: 8 weeks
The Total Nasal Symptom Score (TNSS) will be used to assess the severity of nasal symptoms in subjects. TNSS includes four symptoms: sneezing, rhinorrhea, nasal itching, and nasal congestion, each rated by the patient on a severity scale (0 points indicate no symptoms; 1 point indicates mild symptoms, easily tolerable; 2 points indicate moderate symptoms, annoying but tolerable; 3 points indicate severe symptoms, intolerable, affecting daily life and sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12, with higher scores indicating more severe symptoms. The TNSS scores at baseline and after the 8-week intervention will be recorded and the change will be calculated.
8 weeks
Change in Visual Analogue Scale (VAS) for Nasal Symptoms
Time Frame: 8 weeks
The Visual Analogue Scale (VAS) will be used to evaluate the treatment effect in subjects. VAS scores pertain to four nasal symptoms: sneezing, rhinorrhea, nasal itching, and nasal congestion, with patients marking a point on a 0-10 cm line (0 indicates no symptoms, 10 indicates the most severe symptoms). The total score is the sum of the individual symptom scores, ranging from 0 to 40, with higher scores indicating more severe symptoms. The VAS scores at baseline and after the 8-week intervention will be recorded and the change will be calculated.
8 weeks
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time Frame: 8 weeks
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) will be used to assess the quality of life in subjects. The RQLQ consists of 28 questions that evaluate the degree to which subjects have been bothered by problems in the past 7 days (0 points indicate not bothered at all; 1 point indicates hardly bothered; 2 points indicate occasionally bothered; 3 points indicate moderately bothered; 4 points indicate quite a bit bothered; 5 points indicate very bothered; 6 points indicate extremely bothered). The total score is the sum of the individual question scores, ranging from 0 to 168, with higher scores indicating a greater impact on quality of life. The RQLQ scores at baseline and after the 8-week intervention will be recorded and the change will be calculated.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WK2024016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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