Dataset Information

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

ABSTRACT: 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

DISEASE(S): Ileus In Patients With Colrectal Cancer After Surgery,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Oral And Gastrointestinal-normal Oral And Gastrointestinal Development And Function

PROVIDER: 2462226 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

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:A commercially available product containing three probiotic bacterial strains (Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, and Bifidobacterium bifidum R0071) was previously shown in animal trials to modulate both TH1 and TH2 immune responses. Clinical studies on this combination of bacteria have also shown positive health effects against seasonal winter diseases and rotavirus infection. The goal of this study was to use a well-established in vitro intestinal epithelial (HT-29) cell model that has been shown to constitutively express double-stranded RNA (dsRNA) sensors (Toll-like receptor 3[TLR3], retinoic acid-inducible gene I, melanoma differentiation-associated gene 5, and dsRNA-activated protein kinase). By using the HT-29 cell model, we wanted to evaluate whether or not this combination of three bacteria had the capacity to immune modulate the host cell response to a dsRNA ligand, poly(IM-bM-^@M-"C). Using a custom-designed, two-color expression microarray targeting genes of the human immune system, we investigated the response of HT-29 cells challenged with poly(IM-bM-^@M-"C) both in the presence and in the absence of the three probiotic bacteria. We observed that the combination of the three bacteria had a major impact on attenuating the expression of genes connected to proinflammatory TH1 and antiviral innate immune responses compared to that obtained by the poly(IM-bM-^@M-"C)-only challenge. Major pathways through which the multistrain combination may be eliciting its immune-modulatory effect include the TLR3-TRIF, mitogen-activated protein kinase, and NF-KB signaling pathways.Such a model may be useful for selecting potential biomarkers for the design of future clinical trials The overall design consisted of 3 samples of HT-29 cells treated with poly (I:C)-only, probiotic combination (PC) and poly (I:C) + PC versus unchallenged HT-29 cells. A minimum of four dye-swap hybridizations (4 biological replicates) were performed for each of the 3 samples analyzed. Unchallenged HT-29 cells were controls and challenged HT-29 cells with poly (I:C)-only, PC-only and poly (I:C) + PC were treated samples.

Project description:Genome-wide transcriptional analysis in intestinal epithelial cells (IEC) can aid in elucidating the impact of single versus multi-stain probiotic combinations on immunological and cellular mechanism of action. In this study we used an in vitro intestinal epithelial cell model to investigate the impact of three probiotic bacteria individually or in combination and a surface-layer protein (SLP) partially purified from one of the bacteria on HT-29 cells’ response to a known pro-inflammatory stimulus, polyinosinic:polycytidylic, poly(I:C). Human expression microarray chips were used to evaluate the effect of Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033 and Bifidobacterium bifidum R0071 individually, in combination and of a surface-layer protein (SLP) partially purified from R0052 on HT-29 cells’ transcriptional profile to poly(I:C)-induced inflammation. Hierarchical heat map clustering, Set Distiller and String analyses revealed that the effects of R0052 and R0071 diverged from that of R0033 and R0052-SLP. It was evident from the global analyses with respect to the immune, cellular and homeostasis related pathways that the co-challenge with probiotic combination (PC) vastly differed in its effect from the single strains and R0052-SLP treatments. The multi-strain PC resulted in a greater reduction of modulated genes, found through functional connections between immune and cellular pathways. Cytokine and chemokine analyses based on specific outcomes from the TNF-α and NF-κB signaling pathways revealed single, multi-strain and R0052-SLP specific attenuation of the majority of proteins measured (TNF-α, IL-8, CXCL1, CXCL2 and CXCL10), indicating potentially different mechanisms. These findings indicate a synergistic effect of the bacterial combinations relative to the single strain and R0052-SLP treatments in resolving toll-like receptor 3 (TLR3)-induced inflammation in IEC and maintaining cellular homeostasis, reinforcing the rationale for using multi-strain formulations as a probiotic.

Dataset Information

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets