Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 11:51 PM
Study NCT ID:
NCT01492803
Status:
WITHDRAWN
Last Update Posted:
2017-02-28
First Post:
2011-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2011-11-04', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma LPS levels', 'timeFrame': '32 Weeks', 'description': 'To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.'}], 'secondaryOutcomes': [{'measure': 'Stool colonization with Lactobacillus plantarum', 'timeFrame': '32 Weeks', 'description': 'To quantify the extent that Lactobacillus plantarum populates fecal samples obtained over time in HIV-infected youth receiving probiotics.'}, {'measure': 'Plasma pro-inflammatory cytokines and macrophage activation', 'timeFrame': '32 Weeks', 'description': 'To determine if probiotic colonization of the gastrointestinal (GI) tract with Lactobacillus plantarum decreases levels of plasma pro-inflammatory cytokines and macrophage activation by measuring tumor necrosis factor alpha (TNFα), interferon alpha (IFNα), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-12p70 (IL-12p70), interleukin-10 (IL-10), and soluble CD14 (sCD14) as well as other markers of microbial translocation.'}, {'measure': 'Lymphocyte activation markers', 'timeFrame': '32 Weeks', 'description': 'To determine if probiotic colonization of the GI tract with Lactobacillus plantarum results in decreased levels of T-cell activation markers as measured by shedding of soluble CD27 (sCD27), proportion of CD4 Th17 subsets, and expression of CD38 and HLA DR on CD8 T cells within ART treated and untreated HIV-infected youth.'}, {'measure': 'Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count', 'timeFrame': '32 Weeks', 'description': 'To examine if probiotics have any impact on quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count among the study cohort.'}, {'measure': 'Stool microbial composition and genetic diversity', 'timeFrame': '32 Weeks', 'description': 'To molecularly characterize changes in overall bacteria diversity within the stool specimens of youth treated with probiotics.'}, {'measure': 'Safety labs and adverse events as a measure of acceptability and tolerability of probiotics', 'timeFrame': '32 Weeks', 'description': 'To examine the acceptability and tolerability of probiotics when administered to HIV-infected youth.'}, {'measure': 'Food frequency and probiotics and lifestyle questionnaires', 'timeFrame': '32 Weeks', 'description': 'To explore the effect of diet, smoking, and dietary supplements on plasma pro-inflammatory cytokine levels.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV infection', 'Probiotics'], 'conditions': ['HIV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://atnonline.org', 'label': 'ATN website'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum LPS levels and immune activation among HIV-infected youth.', 'detailedDescription': 'This is a double masked randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum lipopolysaccharide (LPS) levels and immune activation among HIV-infected youth. The study will enroll two cohorts: (1) a cohort of subjects who are not receiving antiretroviral therapy (ART) and have absolute CD4 T-cell count greater than 350 cells/ul and quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml; and (2) a cohort of subjects who are receiving ART and have absolute CD4 T-cell count greater than 350 cells/ul and and quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be considered eligible for enrollment, an individual must meet the criteria listed below.\n\n* Age 13 years and 0 days to 24 years and 364 days at the time of consent\n* Confirmed or suspected to have acquired HIV infection at age 10 years or older\n* HIV-1 infection as documented by any FDA-approved ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, HIV-1 DNA, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to pre-entry\n* Absolute CD4 T-cell count greater than 350 cells/ul at pre-entry\n* Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry\n* Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry\n* Willingness to refrain from regular use of foods/supplements containing probiotics other than that supplied by the study during the course of study participation\n\nExclusion Criteria:\n\nTo be considered eligible for enrollment, an individual must not meet any of the criteria listed below.\n\n* Known hypersensitivity to probiotics\n* Active AIDS-defining condition or acute serious illness\n* Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 50,000 copies/ml during the 24 weeks prior or at pre-entry.\n* Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 400 copies/ml during the 24 weeks prior or at pre-entry\n* Known history of inflammatory bowel disease or similar disorder of the GI tract\n* Current treatment with immune-modulating or immune-suppressive therapy\n* Active malignancy at pre-entry\n* Pregnancy\n* Grade 3 or higher clinical or laboratory toxicities at the time of randomization\n* Regular use of foods or supplements containing probiotics within the 2 weeks prior to randomization (see Appendix V)\n* Concurrent participation in the ATN 061, 071, 081, and/or 101 protocols'}, 'identificationModule': {'nctId': 'NCT01492803', 'briefTitle': 'Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Randomized Placebo-Controlled Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents', 'orgStudyIdInfo': {'id': 'ATN 097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects randomized to the placebo arm.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotics', 'description': 'The probiotics use in the study contains two strains of Lactobacillus plantarum. Each dose of the active study agent contains contains 1 g maltodextrin plus the probiotic bacteria Lp299v (5 x 109 cfu) and Lp299 (5 x 109 cfu).', 'interventionNames': ['Dietary Supplement: Probiotics']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['No other names.'], 'description': 'Probiotic is a live microorganism that when administered in adequate amounts confer a health benefit on the host. It is classified by the FDA as "generally recognized as safe" (GRAS)', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo sticks will contain approximately 1 g maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John Sleasman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}