Dataset Information

Colonisation of Probiotic in Neoplasia.

ABSTRACT: Interventions: The probiotic is Escherichia coli Nissle 1917 (EcN), supplied as Mutaflor, Ardeypharm. Each tablet contains at least 5x108 colony forming units (CFU) EcN. Participants will take either 2 tablets of probiotic or placebo (sugar pill) per day for 14 to 28 days, prior to surgery or colonoscopy. Previous studies have administered probiotic for 28 days. This has been shown to be a safe human dose in earlier phase I trials that unfortunately did not measure colonisation as an end-point. The duration of intervention will depend upon the time participants are consented before their procedure (at least 14 days). Adherence of the intervention will be monitored by probiotic tablet return. Mutaflor and placebo tablets are provided for free from Ardeypharm. Primary outcome(s): Neoplastic colonisation as assessed by DNA sequencing of surplus pathology tissue.[5 years post-enrolment.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Bio-availability

DISEASE(S): Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2468660 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Open label study to evaluate the safety of Lactobacillus rhamnosus GG ATCC 53103 (LGG) in elderly subjects. Fifteen healthy elderly volunteers, ages 65-80 were enrolled in a study in which they received LGG capsules containing 1 x 1010 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 1010 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 Bifidobacterium and Lactobacillus spp. 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>.

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Colonisation of Probiotic in Neoplasia.

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