Dataset Information

Efficacy of Oral Administration of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine based Adjuvant Chemotherapy after Surgery: Randomized, Double-blind, Placebo controlled, Phase-II Study

ABSTRACT: Interventions: One pack (Cystine 700 mg/day and Theanine 280 mg/day) to be taken after breakfast, daily oral administration One pack (placebo) to be taken after breakfast, daily oral administration Primary outcome(s): Incidence rate of Grade 1 or more diarrhea (CTCAE v4.0) Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2640026 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:In animal production the use of probiotics supplements to promote animal health is increasing. The objective of this study was to assess the impact of probiotics administration on global gene expression in dairy cows. Lactating Holstein Friesian cows (n=10) from the North Carolina Agricultural and Technical State University dairy herd were used for the study. Treatment was a 10 ml oral drench of FASTtrak microbial pack (Probiotics) (Conklin Company, Kansas City, MO) at the recommended dose in water or water only (control). This treatment was carried out for 60 days. Whole blood was collected at the beginning (Day 0) and end of the study (Day 60) for microarray analysis. We employed microarray expression profiling as a discovery platform to identify genes with potential association with probiotics supplementation in cows. Gene expression analysis identified 10,859 differentially expressed genes- 1168 upregulated genes and 9691 downregulated gene. Results for pathway analysis showed significant pathways associated with innate immunity such as the Toll-like receptor (TLR) pathway, inflammation response and Wingless (Wnt) signaling pathway. Real-time PCR was used to validate gene expression of members of the TLR and Wnt signaling pathway. Treatment affected the expression of innate and adaptive immune response, cytokine and Wnt pathway genes. Daily administration of probiotics to dairy cows impacts global gene expression and particularly the expression of innate immune genes in dairy cows. Ten animals were enrolled in the study and an initial blood sample was collected (Day 0). Animals (n=5) received either daily supplementations with FASTtrak microbial pack (Probiotics) (Conklin Company, Kansas City, MO) or water daily (control animals) for 60 days. Blood samples were collected at the end of the study from probiotics-treated and control animals for RNA extraction and microarray analysis. In vitro effect of lipopolysaccharide (LPS) endotoxin treatment was evaluated using blood samples collected from probiotics-treated animals (Day 60 samples) to serve as positive control array. A pooled sample was generated by taking equal concentration of RNA from experimental animals in each group. Pooled samples from each group was hybridized on Agilent one color bovine v2 bovine (v2) 4x44KÂ array slides.

Dataset Information

Efficacy of Oral Administration of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine based Adjuvant Chemotherapy after Surgery: Randomized, Double-blind, Placebo controlled, Phase-II Study

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