Ned Stafford/Hamburg, Germany

A medical nutritional supplement can slow the decline in immunity in HIV-positive patients, according to clinical trials results presented this week.

The research, conducted by the medical nutrition unit of French food company Danone, suggests that a formulation that targets the immune system and the gut helps reduce the decline in HIV patients' CD4 cells, targeted by HIV to help the virus replicate.

William Green, of Danone subsidiary Nutricia Advanced Medical Nutrition, told Chemistry World that the results, presented on 14 September at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco, exceeded expectations and that the company now plans to accelerate development toward potential products based on the nutritional concept, currently known as NR100157.

NR100157 is produced as a powder to be dissolved in liquid or mixed in food. It contains five major groups of compounds: prebiotic oligosaccharides (which help decrease systemic CD4 activation), N-Acetyl cysteine (a glutathione precursor), bovine colostrums (which improve gut permeability), long chain polyunsaturated fatty acids (which decrease inflammation and gut permeability), and micronutrients, to help prevent micronutrient depletion. 

In 2007, the company began a double-blind controlled clinical trial in eight nations testing the NR100157 concept on several hundred HIV-positive patients not yet on antiretroviral therapy. A planned interim analysis earlier this year showed that patients taking the supplement showed a significantly reduced decline in CD4 cell count compared to the control group.

The results were so strong and coupled with a lack of safety concerns, that the data and safety monitoring board overseeing the trial advised that there was no real point continuing the trial. Green says the company plans to publish the study in a peer reviewed journal, and the company will now focus on accelerating the development of potential products based on the NR100157 concept.

Green says it is impossible to forecast when the first such products might reach market, but adds: 'I don't think it would be more than five years.' Danone is also in the final stages of developing a drink called Souvenaid to ease Alzheimer's symptoms.

Green says that although the NR100157 clinical trial focused on HIV patients, the prouct could have other uses. 'We believe that we now have the possibility to develop products in various immune related conditions, not just HIV.'

Kimberly Stewart, editor of the Boulder, Colorado-based Functional Ingredients, says: 'The evidence is growing that specific probiotic strains may indeed have significant uses for immune enhancement. This study points to the need for more research regarding probiotics and autoimmune diseases such as HIV and systemic lupus (SLE). If this research shows promise, as an SLE patient myself, I see this as a very positive discovery.' 

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