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Phase 1 clinical trial evaluating whether probiotic supplementation prevents chemotherapy-induced diarrhoea and other intestinal adverse effects in cancer patients.

ABSTRACT: 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

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Cancer-any Cancer,Diarrhoea,Neutropenia,Cancer

PROVIDER: 2467327 | 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: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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Phase 1 clinical trial evaluating whether probiotic supplementation prevents chemotherapy-induced diarrhoea and other intestinal adverse effects in cancer patients.

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