NCT05828498

Brief Summary

This study aimed to determine the effect of the Mediterranean diet as medical nutrition therapy in addition to medical therapy in patients diagnosed with vaginitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

April 12, 2023

Last Update Submit

April 12, 2023

Conditions

Keywords

bacterial vaginitisMediterranean diettreatment

Outcome Measures

Primary Outcomes (1)

  • determine the effect of the Mediterranean diet in the treatment of vaginitis

    Determining the response of bacterial vaginitis patients who follow the Mediterranean diet to the treatment according to the group that does not.

    up to 2 week

Study Arms (2)

grup 1

patients who were on a diet and had a Mediterranean Diet Adherence Scale ≥7 were included in the diet group

Dietary Supplement: THE Mediterranean diet

grup 2

As the control group (group 2), 64 patients participated in the study.

Interventions

THE Mediterranean dietDIETARY_SUPPLEMENT

The Mediterranean diet was applied to the patients with bacterial vaginitis selected randomly. diet content and application techniques were explained to the patient.

grup 1

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbacterial vaginitis is female disease
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It consists of non-pregnant women over the age of 18 who have been diagnosed with bacterial vaginitis.

You may qualify if:

  • Patients diagnosed with bacterial vaginitis and given medical treatment were divided into two groups as diet group and control group. Diagnosed with bacterial vaginitis, given medical treatment, not pregnant mediterranean diet recommended The patients whose diet compliance was controlled and complied with the Mediterranean diet control questionnaire, who came to the control examination after two weeks and were accepted to participate in the study were included in the diet group.

You may not qualify if:

  • pregnant under 18 years old out of control Bacterial vaginitis patients who received 7 or less on the Mediterranean diet compliance scale and did not accept to participate in the study were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye Korkut ATA University

Osmaniye, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

December 1, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations