CTRI/2025/04/085405招募中2/3 期
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)
Vaishya R D1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年1月5日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •This study is a Three Phased approach. Phase.
- •I Prevalence of Colorectal cancer in patients attending a tertiary care Hospital.
- •All patients diagnosed with cancer and attending the OP and IP oncology department of a tertiary care hospital
- •Patients aged 18 years and above
- •Hemodynamically stable patient
- •Patient who provide Informed consent to participate in the study
- •Patients willing and able to undergo demographic assessments. Phase.
- •II and III(A) (Nutritional Screening and Assessment, Pre-operative Colorectal cancer)
- •Patients diagnosed with colorectal cancer (CRC) with the symptoms of Diarrhea and constipation
- •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.
- •Patients who are willing to be observed and monitored for changes in GI symptoms during the intervention period Phase III (B) (Post Operative Colostomy)
- •Postoperative colorectal cancer patients with colostomy bag
- •Patients aged between 18 years and above
- •Individuals willing to participate in the study and provide Informed consent
- •Patients experiencing ostomy symptoms like (Diarrhea, constipation, gas production, color changes odour control, stoma blockage)
- •Participants who can adhere to the prescribed customized diet and intervention regimen.
排除标准
- •This study is a Three phased approach. Phase.
- •I Prevalence of Colorectal cancer in patients attending a tertiary care Hospital.
- •Patients without a cancer diagnosis
- •Patients under the age of 18
- •Patients unable or unwilling to complete the required assessments due to critically ill
- •Patients who do not provide Informed consent to participate in the study
- •pregnant and lactating women. Phase II and III (A)(Nutritional Screening and Assessment, Pre-operative Colorectal cancer)
- •Patients diagnosed with other types of cancer and CRC patients who do not report diarrhea and constipation
- •Patients with severe physical or cognitive impairment that precludes accurate assessment or participation
- •Pregnant and lactating women 4.Patients with dietary restrictions or allergies that prevent the consumption of guar gum or fermented rice
- •Patients who are unwilling or unable to adhere to the personalized diet plan and nutritional intervention
- •Patients with severe condition that may interfere with the intervention.
结局指标
主要结局
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.
时间窗: Till surgery (Preoperative), 6 Weeks (Postoperative)
次要结局
- 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))
研究者
研究点 (1)
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