Relationship of uterine fibroids with thyroid problems and the gut microbes in human
- Conditions
- Leiomyoma of uterus,
- Registration Number
- CTRI/2020/11/029238
- Lead Sponsor
- Manipal Academy of Higher Education
- Brief Summary
**Uterine fibroids (leiomyomas**) are a very common pelvic tumor with an estimated incidence of 20-80% in women of reproductive age. The hyperestrogenic state is a risk factor for fibroids. Heavy menstrual bleeding and pelvic pain weaken their health status & also build psychological (anxiety & depression) & socio-professional (reduced work efficiency & absenteeism at work) impacts on their life*.* The loss of reproductive potential after hysterectomy (central treatment modality) and the hormone therapy rigorously impairs their quality of life. Many women, especially in the Indian scenario are concerned about the poor obstetric outcome after a hysterectomy. The co-existence of thyroid dysfunctions**,**among uterine fibroids, which worsens their symptoms, has been reported in a few recent studies, but its prevalence and the exact cause are still unclear. Current research is focusing on the role of the gut microbiome and microbiome-derived metabolites in health and disease. The microbial flora in the gut actively deconjugates estrogens which may be worth extensive investigation for fibroid pathogenesis. Dysbiosis presents as a shift in the production of various metabolites (Short-chain fatty acids, aromatic & branched-chain amino acids, etc) by bacteria in the gut. These metabolites are anti-inflammatory, they modulate steroid hormones, control immune responses &autoimmunity, maintains gut permeability, and so on. Recent studies reported that the fecal metabolome largely reflects gut microbial composition. One’slifestyle, dietary habits, physical activity & exposure to environmental factors considerably influences gut health as well as fibroid development. There are only limited studies on the relationship between uterine fibroids and thyroid dysfunction. There is a dearth of literature connecting uterine fibroids with gut metabolites and beta-glucuronidase, which is required to investigate the presence of gut dysbiosis.
Hence, the present study is designed to find the relationship of uterine fibroids with thyroid dysfunction and gut dysbiosis on the hypothesis of the role of estrogen as a causative factor for thyroid dysfunction. Women attending the OBG, OPD will be recruited for the study.After the clinical examination and pelvic ultrasound, they will be grouped as women with and without uterine fibroids. They will be screened for inclusion and exclusion criteria, their informed consent will be obtained and the participant information sheet will be given. Detailed medical, menstrual, and gynecological history, history of thyroid symptoms, socio-demographic characteristics, and anthropometric measures will be collected using a proforma. The ’uterine fibroid quality of life and health-related lifestyle questionnaire will be given to the participants. Their serum TSH will be tested, based on the reports, the women with and without fibroids will be stratified into women with euthyroid state and women with thyroid dysfunction.15 participants from each group will be selected based on a matching age and BMI. Their stool sample will be collected and will be analyzed for fecal beta-glucuronidase, short-chain fatty acids, and indole. Data will be analyzed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 752
- Group 1: 1.Premenopausal women with Uterine fibroids 2.
- Age group: 20 – 55 years Group 2 1.Premenopausal women without Uterine fibroids 2.
- Age group: 20 – 55 years For gut metabolite analysis: Matching age and BMI.
Group 1: 1.Malignancies 2.Currently pregnant Group 2: PCOS, heavy menstrual bleeding, endometriosis,adenomyosis , Malignancies, Currently pregnant For gut metabolite analysis: 1.Liver disease 2.Severe renal disease 3.Gastrointestinal diseases 4.Infectious diseases 5.History of major gastrointestinal surgery in the previous year 6.Patientsunderanyantibiotictreatment/probiotic supplement intake for the past 3 months.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum TSH level December 2020 to June 2023
- Secondary Outcome Measures
Name Time Method 1.Estimation of fecal beta glucuronidase 2. Estimation of fecal short chain fatty acids
Trial Locations
- Locations (3)
Dr TMA Pai Hospital,Udupi (Regulated by KMC and KH IEC)
🇮🇳Udupi, KARNATAKA, India
Dr TMA Pai Rotary Hospital,Karkala (Regulated by KMC&KH IEC)
🇮🇳Udupi, KARNATAKA, India
Kasturba Hospital ,Manipal (Regulated by KMC and KH IEC)
🇮🇳Udupi, KARNATAKA, India
Dr TMA Pai Hospital,Udupi (Regulated by KMC and KH IEC)🇮🇳Udupi, KARNATAKA, IndiaVineetha K KPrincipal investigator9048025425vineethakk040694@gmail.com