Actively Recruiting

Phase Not Applicable
Age: 4Years - 14Years
All Genders
NCT06885632

Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

Led by Wecare Probiotics Co., Ltd. · Updated on 2025-03-20

72

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the effect of probiotic gummies on serum metabolite levels, clinical efficacy, and regulation of gut microbiota in children with allergic rhinitis compared with placebo.

CONDITIONS

Official Title

Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

Who Can Participate

Age: 4Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary, written, signed informed consent to participate in this study
  • Ability to complete the study as required by the protocol
  • Age between 4 and 14 years old
  • Meet diagnostic criteria for allergic rhinitis per the 2022 Guidelines for Children
  • Have two or more symptoms such as sneezing, watery discharge, nasal itching, nasal congestion lasting more than 1 hour daily, possibly with eye symptoms
  • Show signs like pale and swollen nasal mucosa, possibly with watery discharge
Not Eligible

You will not qualify if you...

  • Use of drugs affecting intestinal flora continuously for more than 1 week in the month before screening
  • Diagnosis of pulmonary tuberculosis
  • Presence of allergic asthma
  • Presence of nasal polyps or severe nasal septum deviation
  • Severe systemic diseases or malignant tumors
  • Congenital genetic or immunodeficiency diseases
  • Regular use of probiotics or prebiotics within 6 months before screening
  • Severe digestive diseases including severe diarrhea or inflammatory bowel disease
  • Metabolic syndrome including obesity, dyslipidemia, hypertension, diabetes
  • Sinusitis, otitis media, or respiratory tract infection
  • Allergy to probiotic ingredients used in the trial
  • Stopping test samples or adding other drugs during the test affecting data
  • Taking items with similar functions shortly before the test affecting results
  • Inability to participate due to personal reasons
  • Considered unsuitable for participation by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, China, 471000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children | DecenTrialz