A randomized, double-blinded, placebo-controlled pilot study of probiotics in active rheumatoid arthritis

Abstract

SummaryBackgroundTo examine the effect of probiotics as adjunctive therapy for the treatment of rheumatoid arthritis (RA). A sample size of 30 subjects was calculated to determine a moderate effect.Material/MethodsA three month double-blind, placebo-controlled study was performed using probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 capsules administered orally. Inclusion criteria required at least 4 swollen and 4 tender joints and stable medications with no steroids for at least 1 month prior to and during the study. Twenty-nine patients with RA were randomized to treatment. ACR20 responses, serum cytokine levels and safety parameters were assessed.ResultsFifteen patients were randomized to the probiotic group, and 14 to placebo. Three subjects in the probiotic (20%) and one in the placebo group (7%) achieved an ACR20 response (p= 0.33). There was no statistically significant difference between individual components of the ACR20 criteria. Changes in cytokines favored placebo over probiotic. There was a significant improvement in the Health Assessment Questionnaire (HAQ) score in the probiotic group from visit 1 to visit 3 (p=0.02) but no between-group differences.ConclusionsDue to inclusion criteria, patients selected for the study had stable RA with chronic synovitis, and thus it may have been difficult for an adjunctive therapy to demonstrate improvement within 3 months. Although probiotics did not clinically improve RA as measured by the ACR20, it is interesting that there was functional improvement seen within the probiotic group compared to placebo.

Formulation and Design of Probiotic Supplements for Rheumatoid Arthritis Patients

“…[7][8][9][10][11][12] Therefore, it has been attempted to alleviate the symptoms of the disease through normalizing the gut bacterial pattern of the patients; administering probiotic preparations is one possible way to achieve this goal. [13][14][15] Animal studies have shown that various strains of Lactobacillus casei (L. casei) can efficiently decrease inflammatory cytokines in RA. [16][17][18][19] However, it is unclear whether this species can be efficacious for RA patients; the optimum dosage of this probiotic for presenting the consumer with the desired effects has not been determined either.…”

Probiotic Applications in Autoimmune Diseases

“…There was a significant improvement in the Health Assessment Questionnaire score in the probiotic group. Although researchers did not detect clinical improvement, measured by the American College of Rheumatology criteria, authors reported functional improvement within the probiotic supplementation group compared with the placebo [63].…”

“…Some performed studies evaluating the effect of probiotics as an adjuvant therapy for RA treatment have shown no significant results, and some of these conducted studies have smaller number of patients and a short period of evaluation [63,64].…”

“…A double-blind, placebo-controlled clinical trial, performed in the University of Western Ontario, Canada, by Pineda and colleagues [63], evaluated the effect of the oral administration of Lactobacillus rhamnosus and Lactobacillus reuteri for 3 months to 29 RA patients. Fifteen patients were randomized to the probiotic group and 14 to placebo.…”

Oral probiotics as anti-infectious immune response stimulators in the respiratory tract

“…Наоборот, применение в раннем возрасте пробиотиков, содержащих лактобациллы и/или бифидобактерии, снижает вероятность развития аллергических заболеваний [20]. Многие аутоиммунные заболевания ассоциированы с дисбиозом ТК [21], тогда как прием пробиотиков уменьшает выраженность клинических проявлений ревматоидного артрита [22]. Раскрытие молекулярных механизмов патогенеза болезни Крона, при которой генетический дефект передачи противовоспалительных сигналов от компонентов бактериальных клеточных стенок-мурамилпептидов-через NOD2-рецепторы приводит к развитию тяжелого воспалительного заболевания кишечника, также в значительной степени поддерживает тезис о толерогенной функции симбионтных бактерий [23].…”