| CTRI Number |
CTRI/2024/12/077572 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prebiotic and probiotic formulation for management of Endometriosis |
|
Scientific Title of Study
|
Evaluate the efficacy of pre & probiotic formulation for management of Endometriosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Arora |
| Designation |
Chief Genomic Scientist |
| Affiliation |
Research Division of Accurate Diagnostics Pvt. Ltd. Genomic Research and Solutions Pvt. Ltd. |
| Address |
Research Division of Accurate Diagnostics Pvt. Ltd., Kothrud, Pune, Maharashtra, India
Pune
MAHARASHTRA
411038
India |
| Phone |
7304920064 |
| Fax |
|
| Email |
preeticmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Arora |
| Designation |
Chief Genomic Scientist |
| Affiliation |
Research Division of Accurate Diagnostics Pvt. Ltd. Genomic Research and Solutions Pvt. Ltd. |
| Address |
Research Division of Accurate Diagnostics Pvt. Ltd., Kothrud, Pune, Maharashtra, India
Pune
MAHARASHTRA
411038
India |
| Phone |
7304920064 |
| Fax |
|
| Email |
preeticmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Arora |
| Designation |
Chief Genomic Scientist |
| Affiliation |
Research Division of Accurate Diagnostics Pvt. Ltd. Genomic Research and Solutions Pvt. Ltd. |
| Address |
Research Division of Accurate Diagnostics Pvt. Ltd., Kothrud, Pune, Maharashtra, India
Pune
MAHARASHTRA
411038
India |
| Phone |
7304920064 |
| Fax |
|
| Email |
preeticmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gupte Hospital and Centre for Research in Reproduction, Pune, Maharashtra, India, 411004 |
|
|
Primary Sponsor
|
| Name |
Gupte Hospital and Centre for Research in Reproduction |
| Address |
904 Bhandarkar Rd Ganeshwadi Deccan Gymkhana Pune Maharashtra 411004
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preeti Arora |
Gupte Hospital and Centre for Research in Reproduction |
Gynaecology Department, Ground Floor
Pune
MAHARASHTRA |
7304920064
preeticmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gupte Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, (2) ICD-10 Condition: N800||Endometriosis of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Microcrystalline Cellulose: A plant-based, inert substance |
| Intervention |
Probiotic |
Probiotic capsule containing 10 billion CFU of strains of Lactobacillus, Streptococcus and
Bifidobacterium for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 20-50 years with a confirmed diagnosis of endometriosis.
2. Experiencing moderate to severe endometriosis-related pain (e.g., dysmenorrhea, dyspareunia).
3. Complaints of gastrointestinal disturbances (e.g., bloating, IBS-like symptoms) related to endometriosis.
4. Stable hormonal therapy regimen for at least 3 months, if applicable. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, have known allergies
to resveratrol or contraindications to monophasic contraceptive pills, according to World
Health Organization eligibility criteria.
2. Women on previous probiotic supplementation will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in the chronic pain and improved digestive function in women with endometriosis.
2. Effect on CA-125 a biomarker for endometriosis |
At baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Insights into the specific mechanisms by which probiotics exert their effects on
endometriosis could lead to the development of more targeted and effective treatments. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
09/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endometriosis is a chronic inflammatory condition where endometrial-like
tissue grows outside the uterus, affecting about 190 million women worldwide.
It can cause a range of symptoms, including mood disorders and digestive issues
similar to irritable bowel syndrome (IBS).
The gut microbiota, which influences immune function and inflammation, may
play a role in the severity of endometriosis symptoms. Modulating gut
microbiota can reduce systemic inflammation and can be beneficial for managing
the symptoms associated with endometriosis in women.
Current treatments include surgery and medical therapies, highlighting the
need for safe, effective prevention and management options for women of
reproductive age. Regulation of gut
microbiota utilizing antibiotics, fecal bacteria transplantation, probiotics,
nutrients, etc., may provide new ideas for the clinical treatment of
endometriosis. |