Contact information
Type
Scientific
Primary contact
Prof Brian Gazzard
ORCID ID
Contact details
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 20 3315 8239
Brian.Gazzard@chelwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100103-2
Study information
Scientific title
The effect of nutritional supplementation with NR100103-2 on gut health parameters in HIV-1 positive adults with increased gut permeability
Acronym
Ntegra
Study hypothesis
In this proof of concept study it was investigated whether 8 weeks of supplementation with NR100103-2 would contribute to improved gut health
Ethics approval
Ethics Committee, Center of the Foundation for Infectious Disease Studies (Comité de ética FUNCEI) (Argentina), 24/08/2005
Study design
Proof of concept, double blind, randomised controlled parallel-group two arm multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact detials below to request a patient information sheet
Condition
Human immunodeficiency virus (HIV-1)
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Gut permeability after 8 weeks of supplementation with NR100103-2
Secondary outcome measures
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
Overall trial start date
24/11/2005
Overall trial end date
01/02/2007
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
78 planned, 87 actual
Participant 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
Recruitment start date
24/11/2005
Recruitment end date
01/02/2007
Locations
Countries of recruitment
Argentina, Brazil, United Kingdom
Trial participating centre
Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Danone Research (Netherlands)
Sponsor details
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands
+31 317 467 800
barbara.mourmans@danone.com
Sponsor type
Industry
Website
http://www.research.danone.com/means_to_succeed/the_research_center/netherlands
Funders
Funder type
Industry
Funder name
Danone Research B.V. (Tthe Netherlands) Centre for Specialised Nutrition
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary