ABSTRACT
INTRODUCTION: Studies with a follow-up of < 8 weeks have indicated immune-preserving effects of yogurt probiotic supplementation among HIV patients. To evaluate the impact of 25 weeks use of probiotics, a randomized, double blind, controlled study was undertaken on 65 women who were naïve to anti-retroviral treatment. RESULTS: Ten participants were excluded post-randomization due to non-eligibility. Thirty participants were assigned placebo, of whom 25 completed the study versus 19 of 25 completing the study in the probiotics group (p = 0.5). From baseline to 10 weeks follow-up, the CD4 count declined on average 3 CD4 cells/µl (95% Confidence Interval: -97; 91) with placebo versus an increase of 50 cells/µl (95% CI: -61; 162) with probiotics (p = 0.5). From baseline to 25 weeks, the CD4 count increased with 19 cells/µl (95% CI: -90; 129) in the placebo group versus 46 cells/µl (95% CI: -100; 192) with probiotics (p = 0.8). No differences in immune markers, diarrhea incidence or adverse events were observed. DISCUSSION: Lactobacillus GR-1 and RC-14 may be safely consumed at 2 x 10(9) CFU/day by moderately immune compromised HIV patients but this did not universally preserve immune-function. PATIENTS AND METHODS: Women were randomized to receive oral capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 (2 x 10(9) colony forming units) or placebo twice daily for 25 weeks. The CD4 count and immune markers (IgG, IgE, IFNγ and IL-10) were measured at baseline and during follow-up, the occurrence of diarrhea was reported daily.
Subject(s)
Diet Therapy/methods , HIV Infections/immunology , HIV Infections/therapy , Immunologic Factors/administration & dosage , Lacticaseibacillus rhamnosus/immunology , Probiotics/administration & dosage , Administration, Oral , Adult , CD4 Lymphocyte Count , Diet Therapy/adverse effects , Female , Humans , Immunologic Factors/adverse effects , Lacticaseibacillus rhamnosus/pathogenicity , Lacticaseibacillus rhamnosus/physiology , Placebos/administration & dosage , Probiotics/adverse effectsABSTRACT
BACKGROUND: Micronutrient supplementation has been shown to reduce the progression of HIV but does not have an effect on the intestinal barrier or the intestinal microbiota of HIV patients. Studies have suggested that probiotics could potentially complement micronutrients in preserving the immune-function of HIV patients. OBJECTIVE: Assess the impact of micronutrient supplemented probiotic yogurt on the immune function of HIV patients. DESIGN: We performed a randomized, double blind, controlled trial with CD4 count as primary outcome among HIV patients naïve to anti-retroviral treatment. Secondary outcomes included hematological parameters, incidence of diarrhea and clinical symptoms. A total of 112 HIV patients were randomized to receive a micronutrient fortified yogurt with (n = 55) or without additional probiotic Lactobacillus rhamnosus GR-1 (n = 57) for four weeks. RESULTS: An average decline in CD4 count of -70 cells/µL (95% CI: -154 to -15) was observed in the micronutrient, probiotic group versus a decrease of -63 cells/µL (95% CI: -157 to -30) in the micronutrient control group (p = 0.9). Additional probiotic supplementation was well tolerated and not associated with adverse events. No difference between groups was detected in incidence of diarrhea or clinical symptoms. An improvement of hemoglobin levels was observed for all subjects, based upon a mean difference from baseline of 1.4 g/L (SD = 6) (p = 0.02). CONCLUSION: The addition of probiotics to a micronutrient fortified yogurt was well tolerated by HIV patients but was not associated with a further increase in CD4 count after one month.
Subject(s)
Dietary Supplements , Food, Fortified , HIV Infections/drug therapy , Lactobacillus , Micronutrients/therapeutic use , Probiotics/therapeutic use , Adult , Anti-HIV Agents/therapeutic use , CD4 Lymphocyte Count , Diarrhea/epidemiology , Double-Blind Method , Female , HIV Infections/blood , HIV Infections/immunology , Hemoglobins/metabolism , Humans , Incidence , Male , Micronutrients/pharmacology , Outcome Assessment, Health Care , YogurtABSTRACT
OBJECTIVE: To assess, among women with HIV, whether long-term oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 supplementation can prevent bacterial vaginosis (BV) and enhance the cure rate of metronidazole among those with BV. METHODS: A randomized, double-blind, placebo-controlled trial conducted among 65 HIV-infected women with an aberrant microbiota (Nugent score 4-10) who were randomized to receive daily probiotics or placebo for 6 months. Those with BV (Nugent score 7-10) additionally received metronidazole for 10 days (400 mg twice daily). RESULTS: We did not find an enhanced cure rate of BV among women with HIV treated with adjuvant probiotics to metronidazole treatment. Among women with an intermediate vaginal flora, probiotics tended to increase the probability of a normal vaginal flora (odds ratio 2.4; P=0.1) and significantly increased the probability of a beneficial vaginal pH (odds ratio 3.8; P=0.02) at follow-up. CONCLUSION: Supplementation of probiotic L. rhamnosus GR-1 and L. reuteri RC-14 did not enhance the cure of BV among women living with HIV, but may prevent the condition among this population. TRIAL REGISTRATION: NCT00536848.
