NCT06885632

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 13, 2025

Last Update Submit

March 13, 2025

Conditions

Children With Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Changes in the structure of fecal microbiota before and after the intervention.

    Analyzed by 16S rRNA sequencing.

    Week 0 and Week 8

Study Arms (2)

Probiotic group

EXPERIMENTAL

Probiotic pectin gummies(500 million CFU)/2 pellets/day BC99

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

No probiotic pectin gummies/2 pellets/day

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).

Probiotic group
PlaceboDIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).

Placebo group

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Voluntary, written, signed informed consent to participate in this study;
  • be able to complete the study in accordance with the requirements of the test protocol;
  • Age 4-14 years old;
  • Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);
  • Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes;
  • Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;

You may not qualify if:

  • Drugs that affect the intestinal flora (including antimicrobial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used continuously for more than 1 week within 1 month before screening;
  • Patients with pulmonary tuberculosis;
  • Combined with allergic asthma;
  • Those with nasal polyps or severe nasal septum deviation;
  • Patients with severe systemic diseases or malignant tumors;
  • Those with congenital genetic diseases and congenital immunodeficiency diseases;
  • Those who regularly use probiotics or prebiotics within 6 months before the screening period;
  • Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
  • Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
  • Patients with sinusitis, otitis media, or respiratory tract infection;
  • Those who are allergic to the probiotic-related ingredients used in this trial;
  • Those who stop taking the test sample or add other drugs in the middle of the test, and the efficacy cannot be judged or the data is incomplete;
  • Those who take items with similar functions to the test in a short period of time, which affects the judgment of the results;
  • Subjects who are unable to participate in the test due to their own reasons;
  • Subjects who are judged by other investigators to be insuitable to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Luoyang, Henan, 471000, China

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 20, 2025

Study Start

March 10, 2025

Primary Completion

August 10, 2025

Study Completion

November 20, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

CN(1)