Human immunodeficiency virus (HIV-1) Infections and Infestations Human immunodeficiency virus (HIV-1)
Conditions
Interventions
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
Sponsors
Danone Research (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 1. HIV-2 infection 2. Regular NSAIDs intake within two weeks prior to screening and during study 3. Known inflammatory bowel diseases, coeliac disease 4. Known gut bacterial infections /overgrowth 5. Known diabetes type 1, 2 6. Lactose intolerance 7. Clinical renal failure 8. Known liver dysfunction 9. Acute febrile illness 10. Current antibiotic use 11. Current use of corticosteroids or other immune modulating medications 12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements, such as drug or alcohol abuse, mental disorder 13. Participation (or intention to participate) in any other studies involving investigational or marketed products concomitantly or within four weeks prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut permeability after 8 weeks of supplementation with NR100103-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Brazil, United Kingdom
Outcome results
None listed