The effect of a nutritional supplement (NR100103-2) on digestive health in HIV-1 positive adults with increased gut permeability

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: 1. Duration of intervention: 8 weeks 2. Intervention group: 1 sachet of NR100103‐2 once daily for 8 weeks 3. Control group: 1 sachet of control once daily for 8 weeks 4. One sachet contained 19 grams of powder and had to be mixed in water or juice and consumed orally CONDITION: Human immunodeficiency virus (HIV‐1) ; Infections and Infestations ; Human immunodeficiency virus (HIV‐1) PRIMARY OUTCOME: Gut permeability after 8 weeks of supplementation with NR100103‐2 SECONDARY OUTCOME: The effect of supplementation of NR 100103‐2:; 1. For 8 weeks on levels of gut inflammation ; 2. For 4 weeks on gut permeability ; 3. For 4 weeks and 8 weeks on gut absorption; 4. 8 weeks on immune factors in faeces and serum; 5. 8 weeks on faecal flora; 6. Safety parameters INCLUSION CRITERIA: 1. Adults with confirmed HIV‐1 infection 2. At least 18 years of age 3. Males 4. Non‐pregnant (confirmed by pregnancy test) females 5. Non‐lactating females 6. Have not received antiretroviral treatment within past six months, and no antiretroviral treatment anticipated to be required during the study period 7. Abnormal gut permeability (defined as abnormal urine ratio of lactulose /rhamnose (L/R ratio) at screening)
Epistemonikos ID: 6fc580de1d0498d1fb2392909b9319a4da646701
First added on: Mar 20, 2020