| CTRI Number |
CTRI/2025/04/085405 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dietary Intervention with Fermented Rice and Partially Hydrolyzed Guar Gum in colorectal cancer patients |
|
Scientific Title of Study
|
Impact of Dietary Intervention with Fermented Rice (FR) and Partially Hydrolyzed Guar Gum (PHGG) on Bowel regulation in colorectal cancer patients - A Randomized Controlled Trial (DIP - CRC Trial) |
| Trial Acronym |
DIP - CRC Trial. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishya R D |
| Designation |
Research Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research (MAHER) |
| Address |
Meenakshi Academy of Higher Education and Research Vembuliamman Kovil Street West K K Nagar Chennai
No.12 Vembuliamman Kovil Street west K K Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9363076226 |
| Fax |
|
| Email |
vaishyaramesh25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sachdev Meenakshi |
| Designation |
Dietician |
| Affiliation |
Tamil Nadu Government Multi Super Specialty Hospital, Chennai. |
| Address |
Block A, Tamil Nadu Government Multi Super Specialty Hospital Omandurar Chennai
Chennai
TAMIL NADU
600002
India |
| Phone |
9841036607 |
| Fax |
|
| Email |
meenakshibajaj@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachdev Meenakshi |
| Designation |
Dietician |
| Affiliation |
Tamil Nadu Government Multi Super Specialty Hospital, Chennai. |
| Address |
Block A, Room Number 3032 Dietary Department Tamil Nadu Government Multi Sper Specialty Hospital Omandurar Chennai.
Chennai
TAMIL NADU
600002
India |
| Phone |
9841036607 |
| Fax |
|
| Email |
meenakshibajaj@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Block A Tamil Nadu Government Multi Super Specialty Hospital (TNGMSSH) Omandurar chennai Tamil Nadu 600002 |
|
|
Primary Sponsor
|
| Name |
Vaishya R D |
| Address |
No 12, Vembuliamman koil street West K K Nagar chennai 600078 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Sachdev Meenakshi |
TNGMSSH |
Dietary Department and Oncology Departments of Tamil Nadu Government Multi Super Specialty Hospital.
Chennai
TAMIL NADU |
9841036607
meenakshibajaj@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tamil Nadu Government Multi Super Specialty Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Partially Hydrolyzed Guar Gum, Fermented Rice |
Partially Hydrolyzed Guar Gum:
Partially Hydrolyzed Guar Gum (PHGG) is a water soluble dietary fiber derived from the seeds of the guar plant (Cyamopsis tetragonoloba). PHGG selectively increases the beneficial bacteria such as Bifidobacterium and butyrate producing bacteria, production of Short chain fatty acids. PHGG helps in increasing the stool bulk and helps in soften the stool by increasing water content which promotes the GI symptoms like diarrhea and constipation.
Fermented Rice:
Fermented Rice is a traditional rice resulting from the microbial fermentation of Rice. Fermented rice is a probiotic rich food containing beneficial bacteria and short chain fatty acids (SCFAs). Fermented rice when combined with PHGG can enhance the gut microbiota and thereby regulating the bowel function. |
| Comparator Agent |
Standard Hospital Care |
Standard Hospital care is provided to the control group in the pre operative period. Standard Hospital care involves disease specified customized Nutritional plan without PHGG and Fermented rice. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
This study is a Three Phased approach.
Phase - I Prevalence of Colorectal cancer in patients attending a tertiary care Hospital.
1. All patients diagnosed with cancer and attending the OP and IP oncology department of a tertiary care hospital
2. Patients aged 18 years and above
3. Hemodynamically stable patient
4. Patient who provide Informed consent to participate in the study
5. Patients willing and able to undergo demographic assessments.
Phase - II and III(A) (Nutritional Screening and Assessment, Pre-operative Colorectal cancer)
1. Patients diagnosed with colorectal cancer (CRC) with the symptoms of Diarrhea and constipation
2. Patients who Consent to participate in the nutritional screening and assessment Phase
3.Patients who can perform or undergo functional assessments such as handgrip strength, calf circumference and physical performance scales (ECOG, Karnofsky)
4.Patients who agree to follow the personalized diet chart and consume partially hydrolyzed guar gum and fermented rice as part of the intervention.
5. Patients who are willing to be observed and monitored for changes in GI symptoms during the intervention period
Phase III (B) (Post Operative Colostomy)
1. Postoperative colorectal cancer patients with colostomy bag
2. Patients aged between 18 years and above
3. Individuals willing to participate in the study and provide Informed consent
4. Patients experiencing ostomy symptoms like (Diarrhea, constipation, gas production, color changes odour control, stoma blockage)
5. Participants who can adhere to the prescribed customized diet and intervention regimen. |
|
| ExclusionCriteria |
| Details |
This study is a Three phased approach.
Phase - I Prevalence of Colorectal cancer in patients attending a tertiary care Hospital.
1. Patients without a cancer diagnosis
2. Patients under the age of 18
3. Patients unable or unwilling to complete the required assessments due to critically ill
4. Patients who do not provide Informed consent to participate in the study
5. pregnant and lactating women.
Phase II and III (A)(Nutritional Screening and Assessment, Pre-operative Colorectal cancer)
1. Patients diagnosed with other types of cancer and CRC patients who do not report diarrhea and constipation
2. Patients with severe physical or cognitive impairment that precludes accurate assessment or participation
3. Pregnant and lactating women
4.Patients with dietary restrictions or allergies that prevent the consumption of guar gum or fermented rice
5. Patients who are unwilling or unable to adhere to the personalized diet plan and nutritional intervention
6. Patients with severe condition that may interfere with the intervention. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary outcome of the study is to assess the effectiveness of the Nutritional intervention in regulating bowel movements and enhancing stool consistency (Diarrhea and Constipation) in preoperative colorectal cancer patients and to improve the gastrointestinal health like (Diarrhea, constipation, gas production, color changes, odour control and stoma blockage) in postoperative colostomy patients. |
Till surgery (Preoperative), 6 Weeks (Postoperative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Patients who are employed for the study under preoperative colorectal cancer will be followed up everyday till surgery with the intervention of Fermented rice and Partially hydrolyzed guar gum (PHGG). Postoperative colostomy patients will be followed up everyday for 6 weeks with the intervention of fermented rice and partially hydrolyzed guar gum during the hospital stay and once discharged the patient will be followed up through regular hospital visits/phone calls for the better management. |
Till surgery (Preoperative), 6 weeks(Postoperative) |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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 Applicable |
| 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
|
This study aims to evaluate a customized nutritional intervention designed to alleviate gastrointestinal symptoms (Diarrhea, constipation) in Preoperative colorectal cancer patients and Postoperative Colostomy patients. The intervention combines partially hydrolyzed Guar Gum (PHGG) and Fermented rice (FR) for pre-operative colorectal cancer and the study investigates the efficacy of customized ostomy - specific foods incorporating fermented rice and PHGG in managing gastrointestinal symptoms including diarrhea, constipation, gas production, changes in stool color, odour control and stoma blockage with outcomes assessed using Bristol Stool Chart (BSC). |