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
Secondary identifying numbers	100103-2

Submission date: 01/04/2011
Registration date: 19/05/2011
Last edited: 07/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

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

Contact information

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

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact detials below to request a patient 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	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 study start date	24/11/2005
Completion date	01/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	78 planned, 87 actual
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

Locations

Countries of recruitment

Argentina
Brazil
England
United Kingdom

Study participating centre

Chelsea & Westminster Hospital

London
SW10 9NH
United Kingdom

Sponsor information

Danone Research (Netherlands)
Industry

Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704 PH
Netherlands

Phone	+31 317 467 800
Email	barbara.mourmans@danone.com
Website	http://www.research.danone.com/means_to_succeed/the_research_center/netherlands
"ROR"	https://ror.org/01c5aqt35

Funders

Funder type

Industry

Danone Research B.V. (Tthe Netherlands) Centre for Specialised Nutrition

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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