| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D25||Leiomyoma of uterus, |
|
|
Intervention / Comparator Agent
|
|
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 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’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. |