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

ISRCTN	ISRCTN22012202
DOI	https://doi.org/10.1186/ISRCTN22012202
Protocol serial number	100103-2
Sponsor	Danone Research (Netherlands)
Funder	Danone Research B.V. (Tthe Netherlands) Centre for Specialised Nutrition

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Brian Gazzard
Scientific

Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Phone	+44 20 3315 8239
Email	Brian.Gazzard@chelwest.nhs.uk

Primary study design	Interventional
Study design	Proof of concept, double blind, randomised controlled parallel-group two arm multicentre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of nutritional supplementation with NR100103-2 on gut health parameters in HIV-1 positive adults with increased gut permeability
Study acronym	Ntegra
Study objectives	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(s)	Ethics Committee, Center of the Foundation for Infectious Disease Studies (Comité de ética FUNCEI) (Argentina), 24/08/2005
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Gut permeability after 8 weeks of supplementation with NR100103-2
Key secondary outcome measure(s)	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
Completion date	01/02/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	87
Key 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)
Key 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
Date of first enrolment	24/11/2005
Date of final enrolment	01/02/2007

Chelsea & Westminster Hospital

London
SW10 9NH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

07/02/2017: No publications found in PubMed, verifying study status with principal investigator.