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

Not Applicable

Completed

Conditions: Infections and Infestations
Human immunodeficiency virus (HIV-1)
Human immunodeficiency virus (HIV-1)

Registration Number: ISRCTN22012202

Lead Sponsor: Danone Research (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 87

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut permeability after 8 weeks of supplementation with NR100103-2

Secondary Outcome Measures

Name	Time	Method
The effect of supplementation of NR 100103-2:<br>1. For 8 weeks on levels of gut inflammation <br>2. For 4 weeks on gut permeability <br>3. For 4 weeks and 8 weeks on gut absorption<br>4. 8 weeks on immune factors in faeces and serum<br>5. 8 weeks on faecal flora<br>6. Safety parameters