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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  
Status 
Not Applicable 
 
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.

 
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