Effect of Nutrition in the Treatment of Vaginitis

May 22, 2023 updated by: AYBALA TAZEOGLU, Osmaniye Korkut Ata University

Investigation of the Effect of Nutrition and Risk Factors on the Failure of Vaginitis Treatment

Vaginitis is an inflammation or infection of the vagina. It is successfully treated for causative pathogenesis. However, it can be recurrent or treatment-resistant vaginitis. The investigator's aim in this study is to investigate the effect of nutrition and risk factors on the failure of vaginitis treatment.

Study Overview

Detailed Description

Predictively investigated patients diagnosed with vaginitis in the Gynecology and Obstetrics Clinic between January 2022 and April 2022. Patients with a diagnosis of vaginal infection, which were planned for medical treatment, who came for a follow-up examination, whose treatment effectiveness was re-evaluated, and whose data were complete were included in the study. Patients with co-existing gynecological diseases, who did not use the recommended medical treatment regularly, did not come to the follow-up examination within the recommended time, and could not evaluate the effectiveness of the treatment were excluded from the study.

The Obstetrician and Gynecologist gave medical treatment to all patients diagnosed with vaginal infection. The patient was called for control two weeks later. The patients included in the study were divided into two groups, those who recovered after treatment (group 1) and those who were resistant to treatment (group 2) and were compared.

Demographic data (age, gender), menopause, presence of diabetes mellitus, medical history, body mass index (BMI), total body fat and abdominal fat ratio, daily fiber consumption, carbohydrate percentage in the diet, and simple sugar ratio were recorded for the patients included in the study. In addition, the presence of birth in her medical history, delivery technique (vaginal, cesarean section), and history of recurrent vaginitis were questioned and recorded.

Anthropometric measurement Body weight and height measurements of the patients were made. Body mass index was calculated as weight (kilograms) / height squared (square meters).

Body fat measurement TANITA device is a device with 8 electrodes, working with 50 kHz constant current (hand to hand, foot to foot), measuring fat ratio, muscle mass and lean mass value for five different regions (right and left arm, right and left leg, trunk) with 5 different current waves. The measurements were carried out considering the working principles of the bioelectrical impedance analysis (BIA) device. Total body fat and abdominal fat ratio were measured with Tanita. Measurements were calculated as a percentage (%) and recorded.

Nutritional Consumption Record (BeBiS). In the study, information about the patient's diet and the carbohydrate, fat and protein ratios consumed in the diet was obtained by questioning the daily consumed foods when the patient came to the control. The three-day food consumption of the patients was recorded using the BeBis program. First, the percentage of carbohydrates and simple sugars (%) of dietary food intake was calculated and recorded. In addition, the daily pulp consumption amount (grams) was recorded.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Osmaniye
      • Merkez, Osmaniye, Turkey, 80000
        • Aybala Tazeoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Female patients over the age of 18 with a diagnosis of vaginal infection.

Description

Inclusion criteria:

  • admitted to the Gynecology and Obstetrics Clinic with a diagnosis of vaginal infection and medical treatment was planned,
  • regular check-up
  • agreeing to participate in the research,
  • not pregnant
  • over 18 years old

Exclusion Criteria:

  • under 18 years old,
  • pregnant,
  • who refused to participate in the research,
  • who did not come to their check-ups on time for treatment
  • who did not come to their check-ups on time for treatment
  • diagnosed with a psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
grup 1
Those who recover after vaginitis treatment
No intervention was made on the patients. Nutritional status was recorded during the treatment process. Current nutritional status and other risk factors were compared according to recovery status after treatment.
grup 2
those who were resistant to treatment
No intervention was made on the patients. Nutritional status was recorded during the treatment process. Current nutritional status and other risk factors were compared according to recovery status after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of the current nutritional status of patients
Time Frame: up to 1 week
Three-day food consumption of the patients was recorded using the BeBis program. First, daily consumption of carbohydrates, proteins, fats was recorded in grams, and the percentage of carbohydrates and simple sugars (%) of total energy intake was calculated and recorded. In addition, daily pulp consumption amount (gram) was recorded.
up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of vaginitis treatment results and nutritional analysis results, determination of the effect of nutrition on treatment
Time Frame: up to 3 week
At the end of the four-week medical Vaginitis treatment administered by the doctor, the patients who responded positively to the treatment and were resistant to the treatment were divided into groups and the results of the food consumption analysis on Bebis were carbohydrate, protein, fat consumption amount (gram), the percentage of carbohydrate and sugar in total energy, and other risk factors (the presence of birth in The effects of macronutrients and simple sugar consumption on the treatment of vaginitis were determined by comparing each medical history, delivery technique (vaginal, cesarean section), and history of recurrent vaginitis were questioned and recorded.
up to 3 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I don't want the plan to be known.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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