The effect of nutritional supplementation with NR100103-2 on gut health parameters in HIV-1 positive adults with increased gut permeability

Danone Research (Netherlands)0 个研究点目标入组 87 人开始时间: 2011年5月19日最近更新: 2017年2月27日

试验速览

暂无简介。

•1. Adults with confirmed HIV-1 infection
•2. At least 18 years of age
•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)

•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

发起方

Danone Research (Netherlands)