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Dietary Intervention with Fermented Rice and Partially Hydrolyzed Guar Gum in colorectal cancer patients

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) - DIP - CRC Trial.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085405
Enrollment
400
Registered
2025-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C20- Malignant neoplasm of rectum

Interventions

Intervention1: 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 pl

Sponsors

Vaishya R D
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

MeasureTime frame
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.Timepoint: Till surgery (Preoperative), 6 weeks(Postoperative)

Primary

MeasureTime frame
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.Timepoint: Till surgery (Preoperative), 6 Weeks (Postoperative)

Countries

India

Contacts

Public ContactSachdev Meenakshi

Tamil Nadu Government Multi Super Specialty Hospital, Chennai.

meenakshibajaj@hotmail.com9841036607

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026