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CTRI Number  CTRI/2020/11/029238 [Registered on: 19/11/2020] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship of uterine fibroids with thyroid problems and the gut microbes in human  
Scientific Title of Study   Relationship of uterine fibroids with thyroid dysfunction and gut dysbiosis- A prospective observational study 
Trial Acronym  RUTG PO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VINEETHA K K 
Designation  PhD scholar 
Affiliation  Melaka Manipal Medical College 
Address  Department of OBG,Melaka Manipal Medical College,Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576 104
India 
Phone  9048025425  
Fax    
Email  vineetha.kk@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rjeshwari G Bhat 
Designation  Additional Professor 
Affiliation  Melaka Manipal Medical College 
Address  Department of OBG,Melaka Manipal Medical College,Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576 104
India 
Phone  9448624379  
Fax    
Email  rajeshwari.gbhat@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeshwari G Bhat 
Designation  Additional Professor 
Affiliation  Melaka Manipal Medical College 
Address  Department of OBG,Melaka Manipal Medical College,Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448624379  
Fax    
Email  rajeshwari.gbhat@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education(MAHE),Madhav Nagar,Manipal,Udupi (Dt),Karnataka-576 104 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education(MAHE),Madhavnagar,Manipal,Udupi(Dt),Karnataka - 576 104 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vineetha K K  Dr TMA Pai Hospital,Udupi (Regulated by KMC and KH IEC)  Unit 1 and 2,Department of OBG,Dr TMA Pai Hospital, Court Rd, opp. Taluk Office, Brahmagiri, Udupi, Karnataka 576101
Udupi
KARNATAKA 
9048025425

vineethakk040694@gmail.com 
Vineetha K K  Dr TMA Pai Rotary Hospital,Karkala (Regulated by KMC&KH IEC)  Unit 1,Department of OBG,Dr TMA Pai Rotary Hospital, SH1, Karkala, Karnataka 574104
Udupi
KARNATAKA 
9048025425

vineethakk040694@gmail.com 
Vineetha K K  Kasturba Hospital ,Manipal (Regulated by KMC and KH IEC)  Unit 1 to 6,Department of OBG,Kasturba Hospital Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9048025425

vineethakk040694@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
KMC &KH Ethics committee  Approved 
KMC &KH Ethics committee  Approved 
KMC &KH Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D25||Leiomyoma of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  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

 
 
ExclusionCriteria 
Details  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.Patients under any antibiotic treatment/probiotic supplement intake for the past 3 months

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum TSH level  December 2020 to June 2023 
 
Secondary Outcome  
Outcome  TimePoints 
1.Estimation of fecal beta glucuronidase
2. Estimation of fecal short chain fatty acids
3. Estimation of fecal indole
4.Questionnaire to assess quality of life and health related lifestyle of women with uterine fibroids 
1,2 and 3 outcomes will be done from December 2021 to June 2023
4- December 2020 to June 2023  
 
Target Sample Size   Total Sample Size="752"
Sample Size from India="752" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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 modalityand 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 dysfunctionsamong 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’s lifestyle, 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.

 
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