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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
PACTR201110000331360 |
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Date of registration:
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26/10/2011 |
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Primary sponsor: |
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Public title:
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The effect of probiotic supplementation on disease progression and anthropometric status of HIV positive ARV na?ve adults attending a wellness program
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Scientific title:
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The effect of probiotic supplementation on disease progression and anthropometric status of HIV positive ARV na?ve adults attending a wellness program in KwaZulu-Natal, South Africa |
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Date of first enrolment:
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2012-05-02 |
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Target sample size:
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200 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000331360 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
permuted block randomisation (10 blocks of 10),
Numbered containers,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Chara
Biggs |
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Address:
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Durban Road
3201
Pietermaritzburg
South Africa |
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Telephone:
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+27 33 2606153 |
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Email:
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biggsc@ukzn.ac.za |
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Affiliation:
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University of KwaZulu Natal |
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Name:
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Chara
Biggs |
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Address:
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Durban Road
3201
Pietermaritzburg
South Africa |
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Telephone:
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+27 33 2606153 |
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Email:
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biggsc@ukzn.ac.za |
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Affiliation:
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University of KwaZulu-Natal |
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Key inclusion & exclusion criteria
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Inclusion criteria: HIV infected ARV na?ve adults
Between 18 to 44 years of age
CD4+ count of b350 cells/mm3
Exclusion criteria: Pregnant/lactating women
Hepatic/renal insufficiency
Chronic disease eg cancer, diabetes, cardiac
Taking antibiotics for up to 1 month before beginning the trial
Under 18 years and over 44 years
Postmenopausal women
CD4 counts `350 cells/mm3
Taking ARV/HAART
Consuming dietary supplements with either pre or probiotics for up to 1 month before beginning the trial
Age minimum:
18 Year
Age maximum:
44 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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Changes in CD4 count and C reactive protein
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Secondary Outcome(s)
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Changes in anthropometry and fat free mass
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Changes in the incidence of diarrhoea and in quality of life
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Changes in the permeability of the gastrointestinal tract
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Source(s) of Monetary Support
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University of KwaZulu Natal Competetive Research Grant
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