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CompletedNCT05882851Updated May 31, 2023

Effect of Nutrition in the Treatment of Vaginitis

An observational study in 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 2023-05-31.

Sponsored by Osmaniye Korkut Ata University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
106
Ages
18 Years and older
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Vaginitis

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Keywords

  • vaginitis
  • carbohydrates
  • treatment
  • risk factors
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In context

Vaginitis

98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.

This study's enrollment of 106 is below the median of 140 across 22 observational studies indexed under Vaginitis.

Browse Vaginitis 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.

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Who can participate

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

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

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

Groups and cohorts

  • grup 1

    Those who recover after vaginitis treatment

    Behavioral: determination of the current nutritional status of patients

  • grup 2

    those who were resistant to treatment

    Behavioral: determination of the current nutritional status of patients

Interventions

  • Behavioraldetermination of the current nutritional status of patients

    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.

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What researchers measure

Primary outcomes

  1. determination of the current nutritional status of patients

    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.

    Time frame: up to 1 week

Secondary outcomes

  1. comparison of vaginitis treatment results and nutritional analysis results, determination of the effect of nutrition on treatment

    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.

    Time frame: up to 3 week

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Study locations

1 site
  • Aybala Tazeoğlu
    Merkez, Osmaniye 80000, Turkey
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References and documents

Publications

  • Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007 Nov;34(11):864-9. doi: 10.1097/OLQ.0b013e318074e565. PubMed 17621244 ↗
  • Thoma ME, Klebanoff MA, Rovner AJ, Nansel TR, Neggers Y, Andrews WW, Schwebke JR. Bacterial vaginosis is associated with variation in dietary indices. J Nutr. 2011 Sep;141(9):1698-704. doi: 10.3945/jn.111.140541. Epub 2011 Jul 6. PubMed 21734062 ↗
  • Sheard NF, Clark NG, Brand-Miller JC, Franz MJ, Pi-Sunyer FX, Mayer-Davis E, Kulkarni K, Geil P. Dietary carbohydrate (amount and type) in the prevention and management of diabetes: a statement by the american diabetes association. Diabetes Care. 2004 Sep;27(9):2266-71. doi: 10.2337/diacare.27.9.2266. No abstract available. PubMed 15333500 ↗
  • Collins SL, McMillan A, Seney S, van der Veer C, Kort R, Sumarah MW, Reid G. Promising Prebiotic Candidate Established by Evaluation of Lactitol, Lactulose, Raffinose, and Oligofructose for Maintenance of a Lactobacillus-Dominated Vaginal Microbiota. Appl Environ Microbiol. 2018 Feb 14;84(5):e02200-17. doi: 10.1128/AEM.02200-17. Print 2018 Mar 1. PubMed 29269494 ↗

Individual participant data

Plan to share: No — I don't want the plan to be known.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05882851
Lead sponsor
Osmaniye Korkut Ata University
Responsible party
AYBALA TAZEOGLU (assistant professor, Osmaniye Korkut Ata University) — Principal investigator
First posted
May 31, 2023
Start date
Jan 1, 2022
Primary completion
Mar 1, 2022
Completion
Apr 30, 2022
Last update
May 31, 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 May 2023. You cannot join it, but the record below documents what was studied.

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