Condition category
Infections and Infestations
Date applied
01/04/2011
Date assigned
19/05/2011
Last edited
02/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Brian Gazzard

ORCID ID

Contact details

Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
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 August 2005

Study design

Proof of concept, double blind, randomised controlled, parallel-group two arm multicentre study (Argentina: 9 hospitals, Brazil: 3 centres clinics, United Kingdom: 7 centres / clinics)

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

Publication citations

Additional files

Editorial Notes