Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2016-01-31
2017-04-30
Brief Summary
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The secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii) investigate differences between cART-treated HIV-infected INR and non-INR patients with regards to gut microbial composition and mucosal barrier function.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Probiotic compound
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Probiotic compound
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Interventions
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Probiotic compound
Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
Eligibility Criteria
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Inclusion Criteria
* Continuous combined antiretroviral treatment (cART) \>4 years.
* Plasma HIV RNA \<50 copies/mL \>3,5 years.
* Cluster of differentiation(CD)4+ T cell count \<400 cells/µL (OR \>600 cells/µl) \>3.5 years.
* Caucasian
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
Exclusion Criteria
* Serum hepatitis B surface antigen (HBsAg) positive.
* Comorbidity of inflammatory bowel disease, coeliac disease or malnutrition.
* Concomitant use of non-steroid anti-inflammatory drugs (NSAID), corticosteroids, disease-modifying antirheumatic drugs, or other anti-inflammatory pharmaceutical substances.
* Concomitant use of antithrombotic pharmaceutical substances
* Regular (weekly) use of any probiotic substance within 3 months prior to inclusion.
* Use of antibiotics within 3 months prior to inclusion.
* Deranged liver function (serum albumin \<25 g/L or Child-Pugh ≥10)
* Renal failure (estimated glomerular filtration rate (eGFR) \<30 ml/min)
* Heart failure (NYHA class II-IV)
* Intolerance to milk or phenylalanine
* Any reason why, in the opinion of the investigator, the patient should not participate
25 Years
65 Years
MALE
Yes
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Dag Henrik Reikvam
MD PhD
Principal Investigators
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Dag Henrik Reikvam, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital (Ullevaal campus)
Oslo, , Norway
Countries
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References
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Meyer-Myklestad MH, Medhus AW, Stiksrud B, Lorvik KB, Seljeflot I, Hansen SH, Holm K, Hov JR, Kvale D, Dyrhol-Riise AM, Kummen M, Troseid M, Reikvam DH. Probiotics to HIV-Infected Immunological Nonresponders: Altered Mucosal Immunity and Microbial Diversity Restricted to Ileum. J Acquir Immune Defic Syndr. 2022 Jan 1;89(1):77-86. doi: 10.1097/QAI.0000000000002817.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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REK 2015/2125
Identifier Type: -
Identifier Source: org_study_id