| CTRI Number |
CTRI/2025/04/086081 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study tests whether BugSpeaks®, a personalized diet based on gut bacteria, can improve the quality of life of cervical cancer patients undergoing chemo-radiotherapy. |
|
Scientific Title of Study
|
A prospective, randomized, open label study to evaluate safety and efficacy of BugSpeaks®, a microbiota based personalised diet on the quality of life of patients undergoing concurrent chemo-radiotherapy for Carcinoma Cervix of squamous histology. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRPL- BUGSPEAKS-01-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddhartha Nanda |
| Designation |
Professor and HOD, Department of Radiation Oncology |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
B1 Block, Room Number 5, Department of Radiation Oncology, AIIMS, Gate number 1, Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
919713711888 |
| Fax |
|
| Email |
sidnanda@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debojyoti Dhar |
| Designation |
Co-Founder & Director (Business Development and Innovation) |
| Affiliation |
Leucine Rich Bio Pvt Ltd |
| Address |
2nd Floor,HSG Anush,33, 15th Main Road, JP Nagar,4th Phase, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
981839509 |
| Fax |
|
| Email |
ddhar@leucinerichbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Maurya |
| Designation |
Director |
| Affiliation |
ProClin Research Private Limited |
| Address |
2nd Floor,Plot Number 1 Nevri Hills, Gufa Mandir Road, Lalghati
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Leucine Rich Bio Pvt Ltd, 2nd Floor, HSG Anush, 33, 15th Main Road, JP Nagar, 4th Phase, Bangalore - 560078 |
|
|
Primary Sponsor
|
| Name |
Leucine Rich Bio Pvt Ltd |
| Address |
2nd Floor, HSG Anush, 33, 15th Main Road, JP Nagar, 4th Phase, Bangalore - 560078 |
| Type of Sponsor |
Other [Diagnostic Manufacturer ] |
|
|
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 Siddhartha Nanda |
All India Institute of Medical Sciences, Raipur |
B1 Block, Room Number 5, Department of Radiation Oncology, AIIMS, Gate number 1, Tatibandh
Raipur
CHHATTISGARH |
9713711888
sidnanda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BugSpeaks® based personalized nutrition |
BugSpeaks®, is a non-invasive gut microbiota profiling test which profiles the gut microbiota and provides personalised nutritional recommendation based on the gut microbiota. |
| Comparator Agent |
Routine Nutrition |
A Regular Diet refers to the usual dietary pattern that participants were following before enrolling in the study. During the study, participants will be required to continue with the same regular diet without any modifications. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1)Cervical Cancer(Of Squamous Histology) Stage III and IV, Undergoing chemoradiotherapy.
2) Signed Informed Consent Form.
3)Patients who agrees to follow personalised diet for 3 months.
4) Karnofsky Performance Score Greater than 70. |
|
| ExclusionCriteria |
| Details |
1) Individuals with Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis and Crohns disease.
2) Individuals with autoimmune diseases and or under treatment with corticosteroids and or immunosuppressants.
3)Individuals with major surgeries within the last 1 month or gastrointestinal surgery in the last 3month.
4)Operated patients for carcinoma cervix.
5) Individuals undergoing dietary restriction and or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study.
6) Women on Oral contraceptive Pills.
7) Individuals with Intensive Physical Activity (More than 2 hours,3 times per week).
8) Individual taking prebiotics or probiotics during the 4 weeks prior to the beginning of the study.
9) Alcoholic or Drug addicted Individuals.
10) Individuals with regular use of Laxatives ( More than 2 times per week) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effects of microbiota based personalised diet on quality-of-life parameters of cervical cancer patients undergoing chemo and radiotherapy. |
Day 1 to day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate any Adverse Event or Discomfort occurring due to BugSpeaks® based personalised nutrition. |
Day 1 to day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/05/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Malnutrition and muscle wasting are frequently reported in cancer patients, either linked to the tumour itself or caused by oncologic therapies. Understanding the value of nutritional care during cancer treatment remains crucial. In fact, cancer-associated sarcopenia plays a key role in determining higher rates of morbidity, mortality, treatment induced toxicities, prolonged hospitalizations and reduced adherence to anti cancer treatment, worsening quality of life and survival. Since many cancer patients suffer weight loss and are poorly nourished or initially sarcopenic, the importance of screening patients for malnutrition from the beginning of their treatment is well established, as lack of proper nutritional management may limit the response to even the most effective therapy.
More especially, muscle wasting, resulting from mechanical and functional disorders including the imbalance between catabolic and anabolic pathways, is associated with increased surgical complications, poor prognosis, greater treatment related toxicities, a poorer response to anti-cancer therapies, worse quality of life and length hospital stay, On the other hand, cancer therapies may affect the function and composition of gut microbiota, and can trigger dysbiosis affecting multiple metabolic pathways, thus weakening the immune response [6]. We will outline the role of gut microbiota in cancer therapies in terms of toxicity and treatment response and, in turn, how cancer therapies could impact gut microbiota composition and function and vice versa. In this context, we will explore the potential implications of personalized nutritional interventions based on the gut microbiota profile during cancer therapies [7-10]. In this study, we will ascertain how modulating the gut microbiota through nutritional intervention may improve the overall quality of life of the cancer patients and may also improve the efficacy of the treatment. |