CTRI Number |
CTRI/2021/07/034616 [Registered on: 06/07/2021] Trial Registered Prospectively |
Last Modified On: |
02/07/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Probiotic |
Study Design |
Non-randomized, Placebo Controlled Trial |
Public Title of Study
|
Studying the role of probiotics for the treatment of early stage of cervical cancer in Bangladesh |
Scientific Title of Study
|
Studying the role of probiotics as potential biotherapeutics for cervical intraepithelial neoplasia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Abu Syed Md Mosaddek |
Designation |
Principal Investigator & Professor |
Affiliation |
Quest Bangladesh, |
Address |
Department of Clinical trial affairs, Suite:4/3, 4th floor, Block: F, Lalmatia, Dhaka-1209
1207 Other |
Phone |
01711483814 |
Fax |
|
Email |
Drmosaddek1968@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Abu Syed Md Mosaddek |
Designation |
Principal Investigator & Professor |
Affiliation |
Quest Bangladesh, |
Address |
Department of clinical trial affairs, Suite:4/3, 4th floor, Block: F, Lalmatia, Dhaka-1209
1209 Other |
Phone |
01711483814 |
Fax |
|
Email |
Drmosaddek1968@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Abu Syed Md Mosaddek |
Designation |
Principal Investigator & Professor |
Affiliation |
Quest Bangladesh, |
Address |
Department of clinical trial affairs, Suite:4/3, 4th floor, Block: F, Lalmatia, Dhaka-1209
1209 Other |
Phone |
01711483814 |
Fax |
|
Email |
Drmosaddek1968@gmail.com |
|
Source of Monetary or Material Support
|
Ministry of Education, Bangladesh |
|
Primary Sponsor
|
Name |
BANBEIS Ministry of Education |
Address |
1, Jahir Raihan Road, Palashi, Dhaka-1205, Bangladesh.
|
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
Name |
Address |
Purnava Ltd |
Plot No. 1, Milk Vita Road, Section-7
Mirpur, Dhaka-1216, Bangladesh |
|
Countries of Recruitment
|
Bangladesh |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Abu Syed Md Mosaddek |
Center for Injury Prevention and Research, Bangladesh |
Room: 24, House: 23, Road: 23, Dhaka, Bangladesh
|
01711483814
Drmosaaddek1968@gmail.com |
Abu Syed Md Mosaddek |
National Institute of Cancer Research & Hospital (NICRH) |
Room no: 204, NICRH, TB Gate Rd, Mohakhali, Dhaka 1212
|
01711483814
Drmosaddek1968@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Ethical Review Committee, CIPRB |
Submittted/Under Review |
EthicsCommittee,NationalInstituteofCancerResearchandHospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N870||Mild cervical dysplasia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Probiotics |
Lactobacillus acidophilus (2 billion), Lactobacillus bulgaricus (1 billion), Bifidobactaterium bifidum (1 billion), and Fructooligosaccharides (100 mg)
Dose with duration of therapy: Two capsules of probiotics orally two times daily for 6 months. |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
Female
Age: 18 -45 years
Non-pregnant
Willing to take conservative treatment and colposcopy (if required)
Not taking antibiotics, probiotics, vitamins and other medications for any other co morbidity within one month before participating in this research work.
Women irrespective of their ethnicity, parity, phase in their cycle and use of contraception, Smoking, alcohol consumption habits.
Women with a diagnosis of LSIL on their latest PAP smear
Women with a first as well as with a repeat LSIL diagnosis
|
|
ExclusionCriteria |
Details |
Age: female below 18 years and above 45 years
Pregnant
Not willing to take conservative treatment and colposcopy (if required)
Taking antibiotics, probiotics, vitamins and other medications for any other co morbidity within one month before participating in this research work.
Women with a previous history of cervical treatment
Women with HIV or hepatitis B/C positive with autoimmune diseases
Patients suffering from invasive cervical cancer
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
absence or decrease the severity of clinical signs-symptoms. |
Day 0, day 180 |
|
Secondary Outcome
|
Outcome |
TimePoints |
The change in vaginal microbiotia (composition, abundance and diversity).
Lactobacillus level of all groups
Detection of HPV of patients
adverse events |
Day 0 and Day 180 |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="0"
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
|
Phase 4 |
Date of First Enrollment (India)
|
Date Missing |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
15/07/2021 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Cervical cancer is the 2nd leading cause of female cancer and cancer related deaths of female in Bangladesh. Persistent infection with oncogenic Human Papilloma Virus (HPV) is necessary for cervical carcinogenesis. Vaginal microbiota plays a functional role in the persistence or regression of HPV infections. Vaginal dysbiosis associated with depletion of normally dominated vaginal Lactobacillus occurs in cervical cancer. They have been confirmed to boost immunity, eliminate pathogens, moderate side effects of antibiotic therapy etc. Researchers agree with the critical role of probiotics in getting rid of mutagens, delaying the onset of tumors, alleviating the side effects of chemotherapy. 100 participants with a diagnosis of Low-grade Squamous Intraepithelial Lesion (LSIL) on their latest PAP smear/ Visual Inspection with Acetic Acid (VIA) test, will be selected according to the eligible criteria and distributed into group A, B to receive common care (N=50) and probiotic therapy (N=50) for 6 months respectively. After enrollment, a complete history will be taken from the participants and a thorough physical examination will be conducted and recorded. Respondents will fill up a questionnaire. Informed written consents will be taken. Following all safety precautions and aseptic techniques, Cervical and vaginal swab for the detection of HPV, analysis of microbiota and level of Lactobacillus will be collected on day 0, 180 and a new PAP smear/VIA test will be done after 6 months. Respective sample identification number will be assigned. The study information will be kept anonymous strictly. HPV will be detected using the GP5+/6+ HPV PCR with a high-risk HPV probe cocktail in an enzyme immunoassay format. Samples will be inoculated on preselected culture media for both aerobic and anaerobic culture system. Microbial load of samples will be measured quantitatively and identified based on conventional and advance biochemical tests. |