Perioperative administration of probiotics-colorectal cancer-operated by laparoscopy.
Ontology highlight
ABSTRACT:
DISEASE(S): Patients With Colorectal Cancer (ccr) Operated By Laparoscopy
PROVIDER: 2571458 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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.
| 2485704 | ecrin-mdr-crc
Project description:Intervention name : trifluridine/tipiracil
INN of the intervention : trifluridine/tipiracil
Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met.
Intervention name : bevacizumab
INN of the intervention : bevacizumab
Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15.
Control intervention name : fluorouracil
INN of the control intervention : fluorouracil
Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.
Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium)
INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium)
Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen
Primary outcome(s): efficacy
Overall survival
Study Design: Randomized, open-label, comparative study
| 2611617 | ecrin-mdr-crc
Project description:Fifty 8-week-old C57BL/6J mice were randomly divided into five groups of ten mice. The study duration was 28 days and involved three phases, namely an adaptation phase (days 1M-^V7), a treatment phase (days 8-21), and a washout period (days 22-28). During the 14-days treatment period each mouse in the L. gasseri group, the pre-incubation group and the co-incubation group received a daily dose of 1 x 109 viable K7 cells, determined as colony forming units (cfu) on MRS agar, re-suspended in 100 M-5L of saline solution. The suspension was applied orally by the use of plastic feeding tubes for rodent oral gavage. A single dose of E. coli O157:H7 was applied on day 8 of trial (E. coli group, co-incubation group) and day 15 of trial (pre-incubation group). Each mouse received a dose of 5 x 108 viable E. coli O157:H7 cells, determined as colony forming units (cfu) on E. coli O157:H7 agar, re-suspended in 100 M-5L of saline solution. The suspension was applied intra-gastrically by the use of plastic feeding tubes for rodent oral gavage. Throughout the three phases of the study the animals were fed ad libitum a standard mouse diet and had access to water at all times. All mice were weighted weekly on days 0, 7, 14, 21, 28. Their feed intake was assessed weekly by measuring the remaining (unconsumed) food. Mice were also monitored twice daily for the clinical status and behavioral changes. End of the study period, mice were euthanized with CO2 and blood samples were obtained from the heart by cardiac puncture. For microarray analysis 300ul of blood from 4 mice in each group were transferred immediately after the cardiac puncture to tubes containing a pre-loaded RNA-later solution.
2014-01-31 | E-MEXP-3031 | biostudies-arrayexpress
Project description:Gene expression changes in human dendritic cells after contact with either 10e4 or 10e7 CFU of Lactobacillus rhamnosus Lcr35
2011-03-01 | GSE25699 | GEO
Project description:Intervention:
MultiBiotic probiotic formulation containing per capsule:
Lactobacillus rhamnosus (Med 26)9 billion CFU
Lactobacillus acidophilus (Med 27)3.75 billion CFU
Lactobacillus plantarum (Med 25)1.575 billion CFU
Bifidobacterium animalis spp. lactis (Med 13)3 billion CFU
Bifidobacterium breve (Med 12)1.75 billion CFU
Bifidobacterium bifidum (Med 11)500 million CFU
Streptococcus thermophilus (Med 51)1.5 billion CFU
Total21.075 Billion CFU* / 1 capsule
Dosage: 2 capsules twice daily.
Mode of administration: oral
Duration of intervention: 12 weeks
Monitoring: Drug bottles returned (empty or not) to trial investigator.
Primary outcome(s): A composite primary outcome of physical, social, emotional and functional well-being (33 items) will be evaluated according to the FACT-C scale.
The primary outcome will be the mean change in the FACT C total score (33-item) between baseline and end of of the study (12 weeks). [Participants Research Diary collected at the end of the study (12 weeks)];Mean change in Bristol Stool scores between baseline and end of the study (12 weeks).[Participants Research Diary collected at the end of the study (12 weeks)];Mean changes in blood lipopolysaccharide between baseline and end of three chemotherapy cycles.[Blood drawn at baseline and the end of the study (12 weeks).]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy
| 2467327 | ecrin-mdr-crc
Project description:<p>A mechanistic understanding of the health benefits conferred by consumption of probiotic bacteria has been limited by our knowledge of the resident gut microbiota and its interaction with the host. We used fecal samples from a study of twelve healthy individuals aged 65-80 to characterize the structure and functional dynamics of the gut microbiota associated with consumption of the single-organism probiotic, Lactobacillus rhamnosus GG ATCC 53103 (LGG). Samples were collected prior to probiotic consumption (day 0), on day 28 immediately after consuming 10^10 CFU of LGG twice daily for 28 days and day 56, one month after stopping LGG consumption. Our integrative approach incorporated bacterial 16S rRNA gene sequencing, whole-community expression profiling using RNA-seq, and metagenomic sequencing. We highlight the value of combinatorial 'omics methods and concomitant high-resolution informatics to probe the role that probiotics may play on the structure and function of the resident microbiota.</p>
| phs000896 | dbGaP
Project description:The DNA microarray was employed in this study to investigate the gene expression profiles of Escherichia coli treated by an oil-in-water (o/w) microemulsion, in order to better understand the antimicrobial mechanism of the microemulsion as a promising food-grade antimicrobial system. 5,440 open reading frames (ORFs) of E. coli were investigated. 5 ml bacterial cultures with a known inoculum of E. coli cells (1.0 M-CM-^W 109 cfu/ml) was added at 1:1 (v/v) to the microemulsion and incubated on a tube rotator at 200 rpm for 4 h at 37 M-BM-0C for the subsequent DNA microarray analysis.
2014-01-28 | E-GEOD-50556 | biostudies-arrayexpress
Project description:Bulk RNAseq of sigmoid colon biopsies from healthy volunteers and ulcerative colitis patients. Subjects were treated with Placebo or IL-22Fc at different doses, and biopsies were collected at day 0 and day 30 post treatment and prepared for RNA sequencing.
| EGAD00001008816 | EGA
Project description:Interventions: <Fluoropyrimidine+irinotecan+bevacizumab treatment arm>
Prior to enrollment, investigator or subinvestigator select one of the following scheduled regimens for each patient.
1.FOLFIRI+bevacizumab therapy
Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1. After that,
irinotecan 150mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1. At the same time, levofolinate 200mg/ m^2 is given as an infusion of the course of 2 hours on Day1. After that, fluorouracil 400 mg/ m^2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/ m^2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.
2. S-1+irinotecan+bevacizumab therapy with a 3-week cycle
Bevacizumab 7.5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1.
After that, irinotecan 150 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1.
S-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met.
3. S-1+irinotecan+bevacizumab therapy with a 4-week cycle
Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1 and Day 15.
After that, irinotecan 100 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1 and Day 15.
S-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-sur
Primary outcome(s): Overall survival
Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
| 2613990 | ecrin-mdr-crc
Project description:<p><b>Open label study to evaluate the safety of Lactobacillus rhamnosus GG ATCC 53103 (LGG) in elderly subjects.</b> Fifteen healthy elderly volunteers, ages 65-80 were enrolled in a study in which they received LGG capsules containing 1 x 10<sup>10</sup> CFU, twice daily for 28 days and were followed through day 56. The study subjects completed a daily diary, a telephone call on study days 3, 7 and 14 and study visits at the Massachusetts General Hospital Clinical Research Center at baseline, day 28 and day 56. During each visit, the subject diary, interim history, potential adverse effects and concomitant medications were reviewed and vital signs and a physical examination were performed. Routine blood tests were obtained to monitor for safety during visits and nasopharyngeal and stool samples were collected for microbiome analysis. Volunteers interested in participating in the effect of LGG probiotic on the Human whole Blood Transcriptome substudy also had blood drawn for DNA and RNA extraction, after signing the substudy consent form. The main objective of the study was to assess the safety and tolerability of 2 x 10<sup>10</sup> CFU LGG administered orally to elderly subjects for 28 days. Secondary objectives were to evaluate the richness and microbial diversity in nasopharyngeal and stool specimens using pyrosequencing, and to compare cytokine production in response to bacterial stimulation by following the kinetics of mRNA expression of pro and anti-inflammatory genes and different signaling pathways, in relation to changes in stool <i>Bifidobacterium</i> and <i>Lactobacillus spp</i>. The study was reviewed and approved by the Partners Human Research Committee (IRB # 2010P001695) and was registered at ClinicalTrials.gov (<a href="https://clinicaltrials.gov/ct2/show/NCT01274598" target="_blank">NCT01274598</a>). The main results regarding the clinical signs and safety of intervention is published in PLoS One. 2014 Dec 1;9(12):e113456. doi: 10.1371/journal.pone.0113456. eCollection 2014. PMID: <a href="http://www.ncbi.nlm.nih.gov/pubmed/25438151" target="_blank">25438151</a>. RNA sequencing for transcriptome analysis was only done in 11 of the 15 subjects as RNA integrity and quantity had to be optimal for the three times where blood was collected in order for a subject to be included in the study. The information regarding the microbiome data associated with this study is presented in a separate paper, which can be found at dbGaP study accession, <a href="./study.cgi?study_id=phs000896">phs000896</a>, and PMID: <a href="http://www.ncbi.nlm.nih.gov/pubmed/25873374" target="_blank">25873374</a>.</p>
| phs000928 | dbGaP