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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201110000331360 Date registered: 2011/10/26
TRIAL DESCRIPTION
Public title The effect of probiotic supplementation on disease progression and anthropometric status of HIV positive ARV naïve adults attending a wellness program
Official scientific title The effect of probiotic supplementation on disease progression and anthropometric status of HIV positive ARV naïve adults attending a wellness program in KwaZulu-Natal, South Africa
Brief summary describing the background
and objectives of the trial
Treatment to curtail disease progression in well HIV infected individuals is lacking. There is no therapy directed at protecting the gastrointestinal tract which the HIV virus targets. Probiotics have been shown to promote gastrointestinal health. The objectives are to compare changes in CD4+ cell count, haemoglobin, c-reactive protein, albumin, intestinal permeability, morbidity and anthropometric status in those who received probiotics for 6 months to those who received placebo
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Treatment
Anticipated trial start date 2012-05-02
Actual trial start date
Anticipated date of last follow up 2012-05-31
Actual date of last follow up
Anticipated target sample size (number of participants) 200   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation (10 blocks of 10) Numbered containers Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Placebo 2 capsules per day 6 months an identical placebo packed in an identical fashion to the active intervention 100 Placebo
Experimental group UREX-cap-5 2 capsules per day 6 months active components are: Lactobacillus rhamnosus and Lactobacillus reuteri in capsules containing180 mg of a standardized, fine powder consisting of freeze-dried cultures 100

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
HIV infected ARV naïve adults Between 18 to 44 years of age CD4+ count of >350 cells/mm3 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 18 Years 44 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
No 2011/11/04 BREC
Ethics Committee Address
Street address City Postal code Country

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in CD4 count and C reactive protein Baseline Completion of study (6 months)
Secondary Outcome Changes in the permeability of the gastrointestinal tract Baseline At study completion (6 months)
Secondary Outcome Changes in the incidence of diarrhoea and in quality of life Baseline Completion of study (6 months)
Secondary Outcome Changes in anthropometry and fat free mass Baseline Completion of study (6 months)

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Prince Mshiyeni Memorial Hospital Mangosuthu Highway Durban 4060 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
University of KwaZulu Natal Competetive Research Grant University of Durban Westville Westville 3630 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of KwaZulu Natal Durban Road Pietermaritzburg 3201 South Africa University

COLLABORATORS
Name Street address City Postal code Country
Department of Health 330 Langalibalele Street Pietermaritzburg 3201 South Africa
IAEA Palais des Nations Geneva Switzerland

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Ms Chara Biggs biggsc@ukzn.ac.za +27 33 2606153 +27 33 2606270
Street address City Postal code Country Position / Affiliation
Durban Road Pietermartizburg 3201 South Africa University of KwaZulu-Natal
Role Name Email Phone Fax
Public Enquiries Ms Chara Biggs biggsc@ukzn.ac.za +27 33 2606153 +27 33 2606270
Street address City Postal code Country Position / Affiliation
Durban Road Pietermaritzburg 3201 South Africa University of KwaZulu Natal
Role Name Email Phone Fax
Scientific Enquiries Ms Chara Biggs biggsc@ukzn.ac.za +27 33 2606153 +27 33 2606270
Street address City Postal code Country Position / Affiliation
Durban Road Pietermaritzburg 3201 South Africa University of KwaZulu-Natal