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Bacterial VaginitisNCT05828498

The Mediterranean Diet and Bacterial Vaginitis

An observational study of Bacterial Vaginitis, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Bacterial Vaginitis
What is being tested?
THE Mediterranean diet
How many people
126 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2022to 30 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Osmaniye Korkut ATA University

    Osmaniye, 80000

Other trials in Turkey (Türkiye)

About this study

Official title: The Mediterranean Diet Contributes To The Treatment Of Bacterial Vaginitis

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.

Being tested
THE Mediterranean diet
Keywords
bacterial vaginitis, Mediterranean diet, treatment
Medical subject headings
Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05828498
Study groupRoleWhat they receive
grup 1patients who were on a diet and had a Mediterranean Diet Adherence Scale ≥7 were included in the diet group
Receives: Dietary Supplement: THE Mediterranean diet
grup 2As the control group (group 2), 64 patients participated in the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 2 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start1 Dec 2022
  3. Primary completion30 Mar 2023
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828498
Sponsor's protocol ID
OsmaniyeKAUnaad
Status last verified
Apr 2023
First submitted
12 Apr 2023
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bacterial Vaginitis, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

determine the effect of the Mediterranean diet in the treatment of vaginitis (time frame: up to 2 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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