Information:
Fel:
ID
46006
Beskrivning
Principal Investigator: Patricia L. Hibberd, MD, PhD, Massachusetts General Hospital, Boston, MA, USA MeSH: Volunteers, Human,Elderly https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000928 *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 10sup10/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 10sup10/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 *Bifidobacterium* and *Lactobacillus spp*. The study was reviewed and approved by the Partners Human Research Committee (IRB # 2010P001695) and was registered at ClinicalTrials.gov (NCT01274598). 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: 25438151. 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, phs000896, and PMID: 25873374.
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Nyckelord
Versioner (1)
- 2024-04-28 2024-04-28 - Madita Rudolph
Rättsinnehavare
Patricia L. Hibberd, MD, PhD, Massachusetts General Hospital, Boston, MA, USA
Uppladdad den
28 april 2024
DOI
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Creative Commons BY 4.0
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dbGaP phs000928 Effect of LGG Probiotic on Human Whole Blood Transcriptome
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- This subject consent data table contains subject IDs and consent group information.
- This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
- This subject phenotype data table includes subject age, sex, race, ethnicity, and body mass index.
- This sample attributes data table includes body site where sample was collected, analyte type, tumor status, histological type, RNA quality, sample collection day, and flow cell number and lane on which sample was sequenced.
Similar models
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- This subject consent data table contains subject IDs and consent group information.
- This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
- This subject phenotype data table includes subject age, sex, race, ethnicity, and body mass index.
- This sample attributes data table includes body site where sample was collected, analyte type, tumor status, histological type, RNA quality, sample collection day, and flow cell number and lane on which sample was sequenced.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.1
Item
*Inclusion Criteria*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.2
Item
Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
boolean
C1516637 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.3
Item
Age 65-80 years
boolean
C0001779 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.4
Item
Willing to complete the informed consent process
boolean
C0021430 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.5
Item
Able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.6
Item
Is community-dwelling for the past two years
boolean
C4045975 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.7
Item
Has received routine physical in the past two years
boolean
C2973270 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.8
Item
Has no new chronic conditions in the past two years
boolean
C0008679 (UMLS CUI [1,1])
C0746890 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
C0746890 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.9
Item
Identifies a primary care clinician
boolean
C0033131 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.10
Item
Has received recommended preventive services (Task Force for Clinical Preventive Services) for vaccination and cancer prevention/detection, e.g.;
boolean
C0086388 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.11
Item
Pneumococcal vaccination
boolean
C0358314 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.12
Item
Mammography
boolean
C0024671 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.13
Item
Screening colonoscopy for colon cancer
boolean
C0199230 (UMLS CUI [1,1])
C0009378 (UMLS CUI [1,2])
C0009378 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.14
Item
Willing to comply with protocol and report on compliance and side effects during the study period
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.15
Item
Informed consent obtained and signed prior to screening.
boolean
C0021430 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.16
Item
*Exclusion Criteria*
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.17
Item
Subjects meeting any of the exclusion criteria at baseline will be excluded from the study:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.18
Item
Vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period, other than TIV in fall 2012
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.19
Item
History of hypersensitivity to any influenza vaccine components including eggs, egg proteins, gentamicin, gelatin or arginine
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.20
Item
History of avoidance of egg and / or egg based products for any reason, unless they have previously received TIV or LAIV without hypersensitivity
boolean
C0870186 (UMLS CUI [1,1])
C1532666 (UMLS CUI [1,2])
C1532666 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.21
Item
History of Guillain-Barre syndrome
boolean
C0262926 (UMLS CUI [1,1])
C0018378 (UMLS CUI [1,2])
C0018378 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.22
Item
Acute febrile illness within the week prior to immunization - immunization deferred until illness resolved
boolean
C0743842 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.23
Item
Consumption of supplements or food products containing LGG or probiotics for 28 days prior to the start of the study or consumption of yogurt that has the "live and active cultures" seal
boolean
C0525033 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0242295 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.24
Item
Known or suspected allergies to probiotics, *Lactobacillus*, microcrystalline cellulose, gelatin, or antibiotics that may be used to treat LGG bacteremia or infection (i.e. subject able to tolerate at least 2 of the following regimens - Ampicillin or other beta lactam antibiotic, and Clindamycin, and Moxifloxacin)
boolean
C0020517 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.25
Item
Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on the day of enrollment
boolean
C0003232 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.26
Item
Drug or alcohol abuse, defined as the continued use of alcohol despite the development of social, legal, or health problems, within the previous 12 months
boolean
C0038586 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.27
Item
Hospitalization, major surgery or endoscopy within the last 3 months
boolean
C0019993 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C0014245 (UMLS CUI [1,3])
C0679637 (UMLS CUI [1,2])
C0014245 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.28
Item
Scheduled hospital admission or surgery within 3 months of enrollment
boolean
C0184666 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.29
Item
Resident of a nursing home or rehabilitation center
boolean
C0682287 (UMLS CUI [1,1])
C0034993 (UMLS CUI [1,2])
C0034993 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.30
Item
Close and/or household contact with severely immunocompromised persons (e.g. transplant recipients, cancer patients)
boolean
C0332158 (UMLS CUI [1,1])
C0085393 (UMLS CUI [1,2])
C0085393 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.31
Item
Receipt of any of the following medications within the specified time frame
boolean
C0013227 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.32
Item
Antiviral agents for influenza A and B in the prior 2 weeks (anti-influenza medications are unlikely to be needed after LAIV immunization since LAIV will be administered at the end of the influenza season, but should be prescribed if clinically indicated)
boolean
C0003451 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0029347 (UMLS CUI [1,3])
C0029348 (UMLS CUI [1,4])
C0521124 (UMLS CUI [1,2])
C0029347 (UMLS CUI [1,3])
C0029348 (UMLS CUI [1,4])
Elig.phs000928.v1.p1.33
Item
Immune Globulin the prior 6 months
boolean
C0021027 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.34
Item
Immune modulating drugs such as Belimumab, azathioprine, mercaptopurine, methotrexate, hydroxychloroquine or leflunomide at any time or any oral or parenteral corticosteroid in the prior 12 months
boolean
C0021081 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.35
Item
Fingolimod at any time
boolean
C1699926 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.36
Item
Salicylates at doses higher than 163 mg/day for primary prevention of myocardial infarction. (Reye's Syndrome in adults is extremely rare - to our knowledge the oldest reported patient was aged 61 and as of 1989 when Reye Syndrome was more common, it had only been reported in 25 adults. In addition, increasing numbers of adults are being placed on low dose aspirin for primary and secondary prevention of cardiovascular disease, some of whom may also have influenza, but there has been no increase in reports of Reye's Syndrome in adults.)
boolean
C0036077 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.37
Item
Presence of any of the following:
boolean
C3846158 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.38
Item
Grade 2 or higher abnormal vital signs or abnormalities on physical exam during screening (Appendix A) or presence of any wheezing on physical examination at baseline
boolean
C0518766 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.39
Item
Indwelling catheter or implanted hardware/prosthetic device or feeding tube
boolean
C0007439 (UMLS CUI [1,1])
C0021102 (UMLS CUI [2,1])
C0175649 (UMLS CUI [2,2])
C0041281 (UMLS CUI [3,1])
C0021102 (UMLS CUI [2,1])
C0175649 (UMLS CUI [2,2])
C0041281 (UMLS CUI [3,1])
Elig.phs000928.v1.p1.40
Item
Current or within the last 2 years, any episode of bowel leak, acute abdomen, diverticulitis, colitis, bloody bowel movements or peptic ulcer disease, including any surgical procedure or current prescription medications for any of these conditions
boolean
C0021390 (UMLS CUI [1,1])
C0000727 (UMLS CUI [1,2])
C0012813 (UMLS CUI [1,3])
C0009319 (UMLS CUI [1,4])
C0018932 (UMLS CUI [1,5])
C0030920 (UMLS CUI [1,6])
C0000727 (UMLS CUI [1,2])
C0012813 (UMLS CUI [1,3])
C0009319 (UMLS CUI [1,4])
C0018932 (UMLS CUI [1,5])
C0030920 (UMLS CUI [1,6])
Elig.phs000928.v1.p1.41
Item
Current or within the last four weeks, active bowel disease such as an episode of infectious or non-infectious diarrhea, constipation, or vomiting lasting more than 12 hours or current prescription medication for any of these conditions
boolean
C0011991 (UMLS CUI [1,1])
C0009806 (UMLS CUI [1,2])
C0042963 (UMLS CUI [1,3])
C0009806 (UMLS CUI [1,2])
C0042963 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.42
Item
Any history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, history of gastrointestinal tract cancer or metastasis, or inflammatory bowel disease or current prescription medications for any of these conditions
boolean
C0232574 (UMLS CUI [1,1])
C0030305 (UMLS CUI [1,2])
C0685938 (UMLS CUI [1,3])
C0021390 (UMLS CUI [1,4])
C0030305 (UMLS CUI [1,2])
C0685938 (UMLS CUI [1,3])
C0021390 (UMLS CUI [1,4])
Elig.phs000928.v1.p1.43
Item
Any history of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease
boolean
C0262926 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0023890 (UMLS CUI [1,4])
C0341439 (UMLS CUI [1,5])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0023890 (UMLS CUI [1,4])
C0341439 (UMLS CUI [1,5])
Elig.phs000928.v1.p1.44
Item
Underlying structural heart disease such as abnormal native heart valve or congenital abnormality, previous history of endocarditis or valve replacement, Stage IV congestive heart failure or chronic cardiovascular conditions (except hypertension)
boolean
C1290384 (UMLS CUI [1,1])
C0014118 (UMLS CUI [1,2])
C1410969 (UMLS CUI [1,3])
C0018802 (UMLS CUI [1,4])
C0007222 (UMLS CUI [1,5])
C0205191 (UMLS CUI [1,6])
C0014118 (UMLS CUI [1,2])
C1410969 (UMLS CUI [1,3])
C0018802 (UMLS CUI [1,4])
C0007222 (UMLS CUI [1,5])
C0205191 (UMLS CUI [1,6])
Elig.phs000928.v1.p1.45
Item
History of peripheral vascular disease or stroke
boolean
C1881056 (UMLS CUI [1,1])
C0559159 (UMLS CUI [1,2])
C0559159 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.46
Item
Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, neutrophil count <500/mm<sup>3</sup>, or an anticipated drop in the neutrophil count to <500/mm<sup>3</sup> during the study period, or active or planned chemotherapy or radiotherapy
boolean
C4048329 (UMLS CUI [1,1])
C0948762 (UMLS CUI [2,1])
C0948762 (UMLS CUI [2,1])
Elig.phs000928.v1.p1.47
Item
History of collagen vascular or autoimmune disease
boolean
C0262926 (UMLS CUI [1,1])
C0262428 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
C0262428 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.48
Item
History of renal disease
boolean
C0262926 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])
C0022658 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.49
Item
History of chronic obstructive pulmonary disease or asthma
boolean
C0262926 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C0024117 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.50
Item
History of neurologic or neuromuscular diseases
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0027868 (UMLS CUI [1,3])
C0027765 (UMLS CUI [1,2])
C0027868 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.51
Item
History of hematologic diseases
boolean
C0262926 (UMLS CUI [1,1])
C0018939 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.52
Item
Diabetes or thyroid disease or metabolic disorder
boolean
C0011849 (UMLS CUI [1,1])
C0040128 (UMLS CUI [2,1])
C0025517 (UMLS CUI [3,1])
C0040128 (UMLS CUI [2,1])
C0025517 (UMLS CUI [3,1])
Elig.phs000928.v1.p1.53
Item
Active tuberculosis (TB), defined as undergoing work up for suspected active TB infection or currently on treatment for active TB or scheduled for tuberculin test in the next 4 weeks.
boolean
C0151332 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.54
Item
Fever or acute illness or nasal congestion during the baseline visit (LAIV administration)
boolean
C0015967 (UMLS CUI [1,1])
C4061114 (UMLS CUI [2,1])
C0027424 (UMLS CUI [3,1])
C4061114 (UMLS CUI [2,1])
C0027424 (UMLS CUI [3,1])
Elig.phs000928.v1.p1.55
Item
Positive drug or alcohol testing at screening or positive breathalyzer at baseline or an unwillingness to undergo drug and alcohol testing
boolean
C0743295 (UMLS CUI [1,1])
C0085924 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0373483 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0085924 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0373483 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Elig.phs000928.v1.p1.56
Item
Abnormal laboratory tests defined as any of the following:
boolean
C0438215 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.57
Item
White blood cell (WBC) < 3.3 or > 12.0 K/µL
boolean
C0023508 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.58
Item
Neutrophil < 500/mm<sup>3</sup>
boolean
C0948762 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.59
Item
Platelets < 125 K/µL
boolean
C0005821 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.60
Item
Hemoglobin Males: < 12.0 g/dL; Females: < 11.0 g/dL
boolean
C0019046 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.61
Item
Creatinine > 1.8 mg/dL
boolean
C0201976 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.62
Item
Blood urea nitrogen (BUN) > 27 mg/dL
boolean
C0005845 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.63
Item
Aspartate aminotransferase (AST) > 1.25 ULN
boolean
C0201899 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.64
Item
Alanine aminotransferase (ALT) > 1.25 ULN
boolean
C0201836 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.65
Item
Alkaline phosphatase > 2.0 ULN
boolean
C0201850 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.66
Item
Bilirubin (total) > 1.5 ULN
boolean
C0201913 (UMLS CUI [1,1])
Elig.phs000928.v1.p1.67
Item
Glucose (non-fasting ) > 126 mg/dL
boolean
C2347359 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C0337438 (UMLS CUI [1,2])
Elig.phs000928.v1.p1.68
Item
Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody
boolean
C0019693 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Elig.phs000928.v1.p1.69
Item
Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or would make it unlikely the subject could complete the study.
boolean
C1524062 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,4])
C2732579 (UMLS CUI [1,5])
C0012634 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,4])
C2732579 (UMLS CUI [1,5])