The efficacy and safety of probiotic Lactobacillus rhamnosus GG on prolonged, noninfectious diarrhea in HIV Patients on antiretroviral therapy: a randomized, placebo-controlled, crossover study.
OBJECTIVE
The aim of this placebo-controlled, crossover study was to evaluate the efficacy and safety of probiotic Lactobacillus rhamnosus GG (LGG) in ameliorating gastrointestinal symptoms in HIV-infected patients on antiretroviral therapy.


METHODS
Infectious causes for diarrhea (bacteria, ova, parasites, and viruses including cryptosporidium, microsporidia, and cyclospora) were excluded with fecal samples before the study. HIV-infected patients with diarrhea for more than 1 month received in randomized order probiotic LGG preparation (containing viable LGG 1-5 x 1010 cfu/dose) and placebo twice a day for 2 weeks. Gastrointestinal symptoms were assessed daily and included the daily number of bowel movements, classification of stool consistency (watery, semi-watery, loose, firm, or foaming), and Visual Analog Scale (VAS) of gastrointestinal symptoms (flatulence, stomach pain, bloating disorders, general well-being).


RESULTS
Seventeen HIV-infected patients completed the study. There were no significant differences between the treatment groups in the frequency or the consistency of diarrhea. In the VAS assessments of gastrointestinal symptoms, no difference between LGG and placebo could be detected. No adverse events were reported. The number of HIV RNA copies in the blood and CD4 cell counts remained stable during the study.


CONCLUSIONS
Probiotic LGG preparation was well-tolerated in HIV infected patients. No significant differences in noninfectious diarrhea or gastrointestinal symptoms compared to placebo could be observed in this crossover study.
Salminen
Minna K
MK
Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland. minna.salminen@hus.fi
Tynkkynen
Soile
S
Rautelin
Hilpi
H
Poussa
Tuija
T
Saxelin
Maija
M
Ristola
Matti
M
Valtonen
Ville
V
Järvinen
Asko
A
D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D018592:Cross-Over Studies; D003967:Diarrhea / Q000139:chemically induced* / Q000188:drug therapy*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007778:Lactobacillus; D008297:Male; D019936:Probiotics / Q000008:administration & dosage*; D016896:Treatment Outcome
D044966:Anti-Retroviral Agents