Studying the role of probiotics for the treatment of early stage of cervical cancer in Bangladesh

Phase 4

Conditions: Mild cervical dysplasia,

Registration Number: CTRI/2021/07/034616

Lead Sponsor: BANBEIS Ministry of Education

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Applicable

Sex: Female

Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
absence or decrease the severity of clinical signs-symptoms.	Day 0, day 180

Secondary Outcome Measures

Name	Time	Method
The change in vaginal microbiotia (composition, abundance and diversity).	Lactobacillus level of all groups

Trial Locations

Locations (2): Center for Injury Prevention and Research, Bangladesh
🇮🇳
Dhaka,, India
National Institute of Cancer Research & Hospital (NICRH)
🇮🇳
Dhaka, India
Center for Injury Prevention and Research, Bangladesh
🇮🇳Dhaka,, India
Abu Syed Md Mosaddek
Principal investigator
01711483814
Drmosaaddek1968@gmail.com