NCT07378540

Brief Summary

The aim of this study to evaluate the microbial profile in gastritis and healthy patients in different periodontal conditions via next generation technologies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

January 16, 2026

Last Update Submit

January 23, 2026

Conditions

Periodontal DiseasesGastritis

Keywords

gastritismicrobiomemetagenomic analysisdysbiosis

Outcome Measures

Primary Outcomes (1)

  • Salivary microbial profile

    To compare the oral flora profiles of the study groups, a microbiome-based next-generation sequencing approach targeting the 16S rRNA gene was employed. In this metagenomic study, following DNA extraction, phylogenetic classification was performed using the V3-V4 hypervariable regions of the 16S rRNA gene. Using the obtained data, total bacterial diversity and density were compared through alpha and beta diversity analyses. Bacterial taxa that differed between the groups were identified using LEfSe analysis.

    1 month

Study Arms (2)

Gastritis

Patients diagnosed with gastritis via endoscopic method and without other systemic diseases

Other: saliva collection

Systemically healthy

Patients without any systemic disease

Other: saliva collection

Interventions

saliva collectionOTHER

collecting unstimulated saliva

GastritisSystemically healthy

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

older than 18 years, have no systemic disease other than gastritis, non smoker participants

You may qualify if:

  • no systemic diseases other than gastritis non-smoker

You may not qualify if:

  • Participants who took regular medications that could affect of periodontal tissue or oral microbiome pregnancy or lactation Patients who received periodontal treatment within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesGastritisDysbiosis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 30, 2026

Study Start

November 1, 2023

Primary Completion

January 15, 2024

Study Completion

April 1, 2024

Last Updated

January 30, 2026

Record last verified: 2024-03

Locations

TU(1)