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CompletedNCT05828498Updated Apr 25, 2023

The Mediterranean Diet and Bacterial Vaginitis

An observational study in Bacterial Vaginitis, sponsored by Osmaniye Korkut Ata University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Osmaniye Korkut Ata University · Observational

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
126
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

In the study, 256 patients were diagnosed with vaginitis in the Obstetrics and Gynecology clinic. BV was diagnosed in 189 (73.8%) of the patients. Twelve patients with a diagnosis of BV who did not want to participate were excluded from the study. The Mediterranean diet was recommended and explained to 113 of the remaining 177 patients. 49 (42.5%) patients were excluded because the Mediterranean Diet Adherence Scale was \<7. 64 (57.5%) patients who were on a diet and had a Mediterranean Diet Adherence Scale ≥7 were included in the diet group (group 1) As the control group (group 2), 64 patients participated in the study.

A randomized controlled study was designed to investigate the effect of the Mediterranean diet on the treatment of vaginitis in patients diagnosed with BV and given medical treatment. The study was carried out with the collaboration of the Gynecology and Obstetrics Clinic and Diet Clinic.

Patients diagnosed with BV and given medical treatment were divided into two groups a diet group and a control group. Patients who were diagnosed with BV, given medical treatment, and recommended a Mediterranean diet, whose dietary compliance was controlled and compliant 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. Patients diagnosed with BV, given medical treatment, followed up two weeks later, and accepted to participate in the study were included in the control group. In the control examination, the patients were grouped and compared as responsive and resistant after treatment.

Data collection Demographic data (age, gender), anthropometric measurements, presence of comorbid disease, menopausal period, presence of diabetes mellitus (DM), medical history, an average of three-day food consumption, and results of vaginitis treatment in the control examination of the patients included in the study were recorded. In addition, the patient's birth history, delivery technique, vaginal operation history, and vaginitis history were questioned in her medical history.

Anthropometric measurements Body weight (kg), height (cm), total body and abdominal fat ratio of each patient were measured and recorded by the researcher. Body weights were measured by the dietitian using a standard weighing instrument sensitive to 100 g without shoes. Values were determined in kilograms. Height measurements were taken with a Harpenden Stadiometer without shoes, heels touching, feet open at 45º, arms hanging at attention, head in frankfort plane. Values were determined in centimeters. BMI was calculated with the formula of body weight/height squared. Total body and abdominal fat ratio were measured with Tanita. According to the international BMI classification of the World Health Organization; 30 kg/m² was classified as obese (17).

Nutrient consumption analysis The patients were asked to write a diary of the foods they consumed while coming to the control examination. In order for the diary of the foods records to be reliable, tea glass, water glass, bowl, dessert spoon, tablespoon, serving spoon, ladle, 1 slice of bread, 1 meatball measure of meat, chicken, fish, 1 slice of cheese and their quantities were shared visually. Detailed information was given with replica samples.The foods consumed daily were recorded in the Bebis program. The amount of energy received by the patients from the average daily food consumption (kcal/day), what percentage of the daily energy was obtained from carbohydrates (%), and daily protein and fiber consumption amount (gr) were calculated. The distribution of protein consumption amount as animals and vegetables was investigated. The frequency of daily consumption of vegetables, fruits, and grains was recorded.

Mediterranean diet compliance questionnaire The adherence to the Mediterranean diet of the patients in the diet group who came to the control examination was evaluated with the 'Mediterranean Diet Adherence Scale'. The scale includes the type of oil used by the participants in meals, daily olive oil consumption, fruit and vegetable portions, margarine-butter and red meat consumption, weekly wine, pulses, fish-sea products, nuts, pastry consumption, tomato sauce. olive oil and white meat instead of red meat. It consists of 14 questions about the choice, to which all points are added by taking 1 point or 0 points for each question asked according to the consumption amount of the participant (18). Patients with a Mediterranean Diet Adherence Scale score >7 were considered compliant with the diet and were included in the study.

Diagnosis and treatment of bacterial vaginitis The obstetrician and gynecologist made the diagnosis of BV. Vaginal culture and microbiological examination were applied by the physician when necessary. Oral or vaginal antibiotics (metronidazole, clindamycin) were administered according to the BV physician's preference.

02

Conditions studied

  • Bacterial Vaginitis

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Keywords

  • bacterial vaginitis
  • Mediterranean diet
  • treatment
03

In context

Vaginosis, Bacterial

240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.

This study's enrollment of 126 is below the median of 350 across 30 observational studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Osmaniye Korkut Ata University is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
126 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Dietary supplementTHE Mediterranean diet

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

06

What researchers measure

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.

    Time frame: up to 2 week

07

Study locations

1 site
  • Osmaniye Korkut ATA University
    Osmaniye, 80000, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2022 to primary completion in Mar 2023, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2023
First posted
Apr 25, 2023
StartActual
Dec 1, 2022
Primary completionActual
Mar 30, 2023
CompletionActual
Mar 30, 2023
Last update
Apr 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05828498
Lead sponsor
Osmaniye Korkut Ata University
Responsible party
AYBALA TAZEOGLU (assistant professor, Osmaniye Korkut Ata University) — Principal investigator
First posted
Apr 25, 2023
Start date
Dec 1, 2022
Primary completion
Mar 30, 2023
Completion
Mar 30, 2023
Last update
Apr 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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