Does the Pre-operative Use of Probiotic Prevent Ileus In Patients with Colorectal Cancer After Surgery ? A Randomized, Double- Blind, Placebo-Controlled Trial.

STUDY DESIGN Trial samples Product, Dosage & Administration The Probiotics The probiotic which used in this study is Hexbio by B-Corbes. Hexbio is orange-flavoured granules, which prepared in sealed aluminium, foil pouches. Its’safety for consumption was ascertained with an Acute Oral Toxicty Test. The test was carried out by PSB Singapore and dated 06/04/2009. Hexbio contains 6 strains of live bacteria: 1. Lactobacillus acidophilus 2. Lactobacillus casei 3. Lactobacillus lactis 4. Bifidobacterium bifidum 5. Bifidobacterium longum 6. Bifidobacterium infantis These bacteria in this probiotic are all acid and bile resistant. They are highly compatible and able to adhere to the intestinal wall. The concentration of the bacteria in Hexbio is 30 billion colony-forming units. Both probiotic and placebo were prepared in sealed aluminium foil pouches which labelled as A (Placebo) and B (Probiotics) respectively. b) Differences between Probiotic & Placebo Preparation Probiotic Placebo 1. Orange-flavoured granules Ascorbic acid 2. 30 billion colony forming units Skim milk powder 3. Lactose 4. Sealed in aluminium foil pouches 5. Labelled as ‘A’ 6. Weight : 30g Administration (Dosage & Duration) The probiotic and placebo group administered their respective preparation 2 times per day for consecutive 7 days prior to operation day. 1st Dose : 0800H 2nd Dose : 2000H The preparations were administered by diluting it with a glass (50cc) of room temperature water. Instruction i. Subjects are requested to consume trial samples for seven (7) days prior to date of operation. ii. Patients will be followed up in the ward after surgery. Recruitment i. Subjects will be recruited from University Hospital of Malaya; or ii. Subjects will be recruited from Surgical Clinic , Univeristy Hospital ; or iii. Questionnaire will be administered to screen the fulfilment of the criteria prior to enrollment. iv. Qualified subjects will be provided with information of the study and informed consent to be obtained. Study duration Length of the study was continued until patients consume normal diet or discharge. They were reviewed by dietician team for calorie & requirement intake Diet during the study i. Continue with the usual normal diets. ii. Consume given trial samples (Probiotic or Placebo) 2 times a day, either before or after meal. iii. Avoid consuming any other probiotics products to prevent confusion