Clinical trial NCT05882851: Effect of Nutrition in the Treatment of Vaginitis
Official title: Investigation of the Effect of Nutrition and Risk Factors on the Failure of Vaginitis Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginitis
Keywords: vaginitis
carbohydrates
treatment
risk factors
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients over the age of 18 with a diagnosis of vaginal infection.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: determination of the current nutritional status of patients
timeFrame: up to 1 week
Secondary outcomes:
measure: comparison of vaginitis treatment results and nutritional analysis results, determination of the effect of nutrition on treatment
timeFrame: up to 3 week
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Aybala Tazeoğlu
state: Osmaniye
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.