Clinical trial · Interventional
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies: A Randomized, Placebo-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We hypothesize that micronutrient fortified probiotic yogurt can improve nutritional status and enhance immunity parameters in subjects HIV/AIDS and other immunodeficiencies. We have developed a micronutrient-fortified probiotic yogurt that has safe and beneficial levels of micronutrients for human consumption. This has been undertaken with the guidance of Edward Farnworth, a senior research scientist at Agri-Food Canada-Food Research and Development Centre, St. Hyacinthe, Quebec We will now measure nutritional parameters (height, weight, serum albumin, serum nutrient levels, blood urea, liver function tests (AST, ALT)) to determine if there is a statistically significant difference between the various levels of fortified probiotic yogurt and the placebo on the nutritional parameters of the subjects consuming the yogurt. We will measure immunological parameters (CD4 lymphocyte count, CBC, levels of TNFα, IL-12, IL-10, and G-CSF \[Kim, et.al. 2006\]) in order to determine if there is a statistically significant difference using fortified probiotic yogurt compared to a placebo. In addition, we will determine if the micronutrient-fortified probiotic yogurt has a significant impact on the overall quality of life for the subjects using the "linear analogue self assessment" tool \[Kaiser, et.al 2006\].
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Second Primary | Second Primary Malignant Neoplasm | ALIAS | 0.90 |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Probiotic Yogurt A: Kaiser micronutrients | Dietary Supplement | — | UNRESOLVED |
| Probiotic Yogurt B: with various micronutrients | Dietary Supplement | — | UNRESOLVED |
| Probiotic yogurt C: with basic micronutrients | Dietary Supplement | — | UNRESOLVED |
| Probiotic Yogurt D: Placebo -- no added micronutrients | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Dietary Supplement: Probiotic Yogurt B: with various micronutrients
- Dietary Supplement: Probiotic Yogurt A: Kaiser micronutrients
- Dietary Supplement: Probiotic yogurt C: with basic micronutrients
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients
Primary outcomes (1)
- measure
- Statistically significant improvement of immune status (CD4) Statistically significant improvement of nutritional status
- timeFrame
- Baseline and Follow-up for each yogurt type
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically tested CD4 lymphocyte count between 200-400cells/mL (HIV population) * Confirmed cancer by physician (cancer population) * Confirmed HIV by physician (HIV population) Exclusion Criteria: * Opportunistic infection * Mental illness impairing ability to comply with study * Pregnancy * Currently consuming micronutrient supplement or probiotic * Clinical history of lactose-intolerance or cow's milk allergies * Require surgery, radiation or chemotherapy during the study
References
Publications (13)
- BACKGROUNDDangour AD, Clemens F, Elbourne D, Fasey N, Fletcher AE, Hardy P, Holder GE, Huppert FA, Knight R, Letley L, Richards M, Truesdale A, Vickers M, Uauy R. A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People And n-3 Long-chain polyunsaturated fatty acids (OPAL) study protocol [ISRCTN72331636]. Nutr J. 2006 Aug 31;5:20. doi: 10.1186/1475-2891-5-20. PMID 16945130
- BACKGROUNDAnukam K, Osazuwa E, Ahonkhai I, Ngwu M, Osemene G, Bruce AW, Reid G. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect. 2006 May;8(6):1450-4. doi: 10.1016/j.micinf.2006.01.003. Epub 2006 Mar 29. PMID 16697231
- BACKGROUNDAnukam KC, Osazuwa EO, Osadolor HB, Bruce AW, Reid G. Yogurt containing probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 helps resolve moderate diarrhea and increases CD4 count in HIV/AIDS patients. J Clin Gastroenterol. 2008 Mar;42(3):239-43. doi: 10.1097/MCG.0b013e31802c7465. PMID 18223503
- BACKGROUNDAustin J, Singhal N, Voigt R, Smaill F, Gill MJ, Walmsley S, Salit I, Gilmour J, Schlech WF 3rd, Choudhri S, Rachlis A, Cohen J, Trottier S, Toma E, Phillips P, Ford PM, Woods R, Singer J, Zarowny DP, Cameron DW; CTN 091/CRIT Cartenoids Study Group. A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome. Eur J Clin Nutr. 2006 Nov;60(11):1266-76. doi: 10.1038/sj.ejcn.1602447. Epub 2006 May 24. PMID 16721396
- BACKGROUNDBourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 1: micronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):377-85. PMID 17066209
- Cunningham-Rundles S, Ahrne S, Bengmark S, Johann-Liang R, Marshall F, Metakis L, Califano C, Dunn AM, Grassey C, Hinds G, Cervia J. Probiotics and immune response. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S22-5. doi: 10.1016/s0002-9270(99)00813-8.