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Gut Health Study - effectiveness of probiotics (OMNI-BiOTiC 10) combined with individual nutritional counselling with focus on prebiotic nutrition compared to solely individual nutritional counselling to improve gastrointestinal symptoms of bowel cancer survivors - a prospective double-blind randomized placebo-controlled trial

ABSTRACT: Interventions: Group 1: Nutritonial counselling focussing prebiotic and high fibre nutrition + probiotic supplement Group 2: Nutritonial counselling focussing prebiotic and high fibre nutrition + placebo Primary outcome(s): gastrointestinal symptoms (difference 12 weeks after baseline) measured by EORTC-C30 /C29) Study Design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: treatment

DISEASE(S): Functional Intestinal Disorder, Unspecified

PROVIDER: 2721103 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Arm 1 : Intervention group - These patients will receive an intensive individualised diet and lifestyle intervention for 8 weeks. There will be counselling by a reseacher (dietitian) using a standard protocol: the American Dietetic Association Medical Nutrition Therapy (ADA MNT) protocol for cancer patients (ADA 1998). Each visit will take between 20 and 30 minutes one on one with the dietitian for dietary counselling. These patients will receive dietary counselling at baseline, week 4 and week 8 only. The main goal of an intensive counselling intervention is to enable every patient to achieve his or her calculated energy and protein requirements. This will involve the prescription of a therapeutic diet which will be further modified to provide for individual requirements. Advice on managing symptoms that negatively impact on eating and nutritional status will be also provided. Individually tailored sample meal plans and recipe suggestions will also be provided as and when required during the face-to-face sessions. General advice on physical activity will also be provided. Dietetic counselling will be conducted at baseline, week 4 and week 8 then followed up by motivational sessions that will be reinforced at regular intervals through phone calls once a week during the 8 week intervention. Arm 2: Control group - These patients will receive the standard practice of the clinic (ie, a general nutrition talk by the dietitian and information on nutrition and cancer in form of a booklet). The booklet used in this study is in English and Malay language . Those who are assessed as having moderate and severe malnutrition will be referred to see a dietitian for nutrition counselling. However, the intervention group will receive tailored and more intensive and ongoing nutr Primary outcome: nutritional status as determined by PG-SGA score.[At baseline and at 4, 8, 20 weeks after intervention commencement.] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

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