| CTRI Number |
CTRI/2026/01/102020 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prebiotic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Observing patterns of microbiome and Improving Recovery in Cancer Patients Using Personalized Prebiotics |
|
Scientific Title of Study
|
Improved Cancer Recovery Leveraging The Microbiom (With Personalized Prebiotics) |
| 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 Rajeev Kumar |
| Designation |
Scientist and Head. |
| Affiliation |
Cachar Cancer Hospital and Research Centre |
| Address |
Research Dvision, Dr S Krishnamurthi Centre for Research and Education in Cancer.
Cachar
ASSAM
788015
India |
| Phone |
919435378008 |
| Fax |
|
| Email |
admin@cacharcancerhospital.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar |
| Designation |
Scientist and Head. |
| Affiliation |
Cachar Cancer Hospital and Research Centre |
| Address |
Research Division, Dr S Krishnamurthi Centre for Research and Education in Cancer.
Cachar
ASSAM
788015
India |
| Phone |
919435378008 |
| Fax |
|
| Email |
admin@cacharcancerhospital.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar |
| Designation |
Scientist and Head. |
| Affiliation |
Cachar Cancer Hospital and Research Centre |
| Address |
Research Division, Dr S Krishnamurthi Centre for Research and Education in Cancer.
Cachar
ASSAM
788015
India |
| Phone |
919435378008 |
| Fax |
|
| Email |
admin@cacharcancerhospital.org |
|
|
Source of Monetary or Material Support
|
| Cachar Cancer Hospital & Research Centre (CCHRC).
Dr. S. Krishnamurthi Centre for Research and Education in Cancer, Cachar Cancer Hospital and Research Centre, Silchar-788015, Assam, India. |
|
|
Primary Sponsor
|
| Name |
Cachar Cancer Hospital & Research Centre (CCHRC). |
| Address |
Dr. S. Krishnamurthi Centre for Research and Education in Cancer, Cachar Cancer Hospital and Research Centre, Silchar-788015, Assam, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Iom Bioworks Pvt Ltd |
Gandhi Krishi Vignana Kendra Centre For Cellular & Molecular Platforms, National center for biological science, Rajiv Gandhi Nagar, Kodigehalli, Bengaluru, Karnataka 560065 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajeev Kumar |
Cachar Cancer Hospital & Research Centre |
Research Division, Dr S Krishnamurthi Centre for Research and Education in Cancer.
Cachar
ASSAM |
94353 78008
admin@cacharcancerhospital.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Personalized prebiotic supplementation. |
Participants will receive personalized prebiotic supplementation based on their baseline gut microbiome profile. Stool samples will be collected at baseline (Week 0) to assess gut microbial composition. Based on identified microbial patterns, an appropriate prebiotic will be selected for each participant. The selected prebiotic will be administered once daily for a total duration of 8 weeks. Follow-up stool samples will be collected at the end of the intervention period (Week 8) to assess changes in gut microbial composition and related outcomes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Condition: Diagnosed with Upper GI cancer (for patient group).
BMI: 18–29.9 kg/m².
Other: Willingness to provide stool samples and provide informed consent. |
|
| ExclusionCriteria |
| Details |
Chronic illnesses requiring hospitalization or known GI disorders.
Major surgery/hospitalization in the last 6 months.
Long-term antibiotic/anti-tubercular treatment.
COVID-19 infection within the last 3 months.
Intolerance to prebiotic ingredients (for the interventional phase). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in gut microbiota composition and identification of bacterial signatures associated with cancer treatment. |
Baseline (Day 1), Post-treatment (Day 60), Follow-up (Day 90–150) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in microbial diversity, correlation with clinical and demographic variables, and patient-reported wellness outcomes (sleep, fatigue, stress). |
Baseline, 8 weeks post-intervention.
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/02/2026 |
| 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="6"
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
|
This is a two-phase clinical study evaluating changes in the gut microbiota of cancer patients undergoing standard cancer treatment and the impact of microbiome-based interventions on recovery. Phase I is a prospective, single-arm observational study assessing gut microbiota composition before treatment, post-treatment, and up to 2 months after treatment to identify microbial signatures and dysbiosis associated with cancer therapy.Phase II is an interventional study evaluating the effect of personalised prebiotic and nutritional interventions on gut microbiota, assessed before intervention and after 2 months of intervention. |