- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05882851
Effect of Nutrition in the Treatment of Vaginitis
Investigation of the Effect of Nutrition and Risk Factors on the Failure of Vaginitis Treatment
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Osmaniye
-
Merkez, Osmaniye, Turkey, 80000
- Aybala Tazeoğlu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OsmaniyeKAUnad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.