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Evaluation of the use of Probiotics in the intestinal flora, nutritional status and immune system of patients who underwent Surgery to Remove the Stomach for Gastric Cancer

ABSTRACT: Interventions: This is a three-arm, single-blind, randomized controlled clinical trial. Patients (n = 36) will be randomly distributed into three blocks (G1,G2,G3). Patients will be randomly assigned to three blocks (G1,G2,G3) in a 1:1 ratio to receive probiotics (G1 group) with formulation: Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37 TM, Bifidobacterium lactis Bi-04TM, Bifidobacterium lactis Bi-07TM, Bifidobacterium bifidum Bb-02TM), associated with a standard nutritional guidance protocol. In the G2 (control) group, conventional treatment will be performed with a standard nutritional guidance protocol, without the use of probiotics. The intervention product (probiotic capsules) will be distributed and packaged according to the days of the research and inpatient ward, which will not be disclosed during the entire period of the research, the tests will be carried out on alternate days as detailed in the recruitment, in order not to cross-referencing of information between previously blinded participants. In the case of the G3 group, they will receive the probiotic capsules at the same time as the G1 group. Both groups that will use probiotic capsules should continue using them for 7 days, without any break in follow-up. The groups will be monitored twice a day in person or by telephone, in order to avoid loss of capsule intake.;G07.203.300.456.500 Primary outcome(s): To evaluate the use of perioperative probiotics to improve the nutritional and immunological clinical status of patients undergoing gastrectomy for gastric cancer

DISEASE(S): Gastric Neoplasms,Gastrectomy

PROVIDER: 2756417 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night). Intervention 2: group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening. Intervention 3: group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening.;Treatment - Drugs;Treatment - Drugs;Treatment - Drugs;group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night);group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening;group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening Primary outcome(s): Diarrhea grade. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Common Toxicity Criteria system.;Stool consistency score. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Bristol scales.;Blood cell counts. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: cell counter machine.;Serum IgA level. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Autoanalyzer machine. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.

Project description:Interventions: 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 ProbioticPlacebo 1.Orange-flavoured granulesAscorbic acid 2.30 billion colony forming unitsSkim 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. Primary outcome(s): Return of normal gut function as defined as the oral tolerance of 80% or more of calculated nutritional requirements (kcal /day) for a minimum consecutive period of 48 hours. Caloric requirement was calculated according to the Harris Benedict equation: Energy Requirement Equations Basal Energy Expenditure (BEE) Men: BMR = 66 + (13.7 X wt in kg) + (5 X ht in cm) - (6.8 X age in years) Women: BMR = 655 + (9.6 X wt in kg) + (1.8 X ht in cm) - (4.7 X age in years) Calculated Caloric Requirements (CCR): CCR = BEE x activity factor (1.2) x stress factor (1.4) Patients were followed up in the ward after surgery and reviewed by Dietitian Team for daily calorie & requirement intake [Length of the study was continued daily until return of normal gut function] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

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Evaluation of the use of Probiotics in the intestinal flora, nutritional status and immune system of patients who underwent Surgery to Remove the Stomach for Gastric Cancer

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