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The effect of probiotic in HIV patients

Phase 2
Conditions
HIV.
Unspecified human immunodeficiency virus [HIV] disease
Registration Number
IRCT2016092228308N1
Lead Sponsor
Vice chancellor for research Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Confirm HIV infection by Western blot analysis; lack of criteria for initiating treatment according to national HIV guideline; no use of probiotic supplements in the past 6 months ; have a consent to conduct research Exclusion criteria:On Highly Active Anti Retroviral Therapy (HAART) regimens; active addiction; opportunistic infection in the past; Liver or Kidney failure; inflammatory bowel disease and other well known Gastrointestinal pathology; active infection and fever; younger than 18 and older than 65 years; have a cancer, pregnancy and breastfeeding; being dependent on alcohol; a history of allergy or sensitivity to the probiotic or lactose intolerance; use of other supplement drugs, and multivitamins; Use of growth hormone, testosterone or anabolic agent during the last 6 months.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
CD4. Timepoint: At baseline ,three months later, and after 6 months. Method of measurement: Based on the number per microliter by laboratory blood tests.
Secondary Outcome Measures
NameTimeMethod
CRP. Timepoint: At baseline ,three months later, and after 6 months. Method of measurement: Based on the number per microliter by laboratory blood tests.;Side effects. Timepoint: every 4 week after intervention. Method of measurement: Based on side effects checklist.
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