Tab Application Banner
  • Users Online: 217
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 
 
ORIGINAL ARTICLE
Ahead of Print

A prospective, randomized, single-center, two-arm, open-label study to evaluate the efficacy of biotherapi®, a two-strain bacillus probiotic blend, as an adjunctive therapy in the treatment of rheumatoid arthritis


 Department of Rheumatology, Yashoda Hospitals, Secunderabad, Telangana, India

Correspondence Address:
Arindam Nandy Roy,
Department of Rheumatology, Yashoda Hospitals, Behind Hari Hara Kala Bhavan, S. D. Road, Secunderabad - 500 003, Telangana
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/injr.injr_281_20

Objective: Probiotics have been shown to alleviate the symptoms of rheumatoid arthritis (RA) by normalizing the composition of gut microbiota. The objective of this study was to evaluate the effect of twice-daily Biotherapi® (Sanzyme Private Limited, India) as an adjunct to standard of care on disease activity and functional ability of patients with RA. Methods: In this prospective, randomized, single-center, two-arm, open-label study, patients were randomized (1:1) to receive twice-daily adjunctive Biotherapi® (n = 125) or standard of care alone (n = 125) for 12 weeks. The primary endpoint was the change from baseline to days 45 and 90 in the Disease Activity Score-28-erythrocyte sedimentation rate (DAS-28-ESR). Results: Standard of care alone and adjunctive Biotherapi® significantly reduced the mean DAS-28-ESR at days 45 and 90 (P < 0.05). However, the reduction from baseline was greater in patients receiving adjunctive Biotherapi® compared to standard of care alone at day 45 (–0.67 ± 0.77 vs. −0.15 ± 0.84, P < 0.0001) and day 90 (–1.21 ± 0.99 vs. –0.48 ± 0.69, P < 0.0001). Consequently, compared to standard of care, more patients achieved remission (4.3% vs. 23.6%) and showed good (6.52% vs. 35.45%) and moderate (31.5% vs. 41.81%) European League Against Rheumatism response at 90-day Biotherapi®. A similar pattern of improvement in the scores including Health Assessment Questionnaire was observed. No clinically significant changes in the laboratory parameters were reported during the study. Conclusion: Twice-daily supplementation with Biotherapi® probiotic blend as an adjunct to standard-of-care treatment for RA is beneficial for alleviation of severity and symptoms of the disease and results in improvement in patients' quality of life.


Print this article
Search
 Back
 
  Search Pubmed for
 
    -  Roy AN
    -  Kumar YA
    -  Fatima SS
 Citation Manager
 Article Access Statistics
 Reader Comments
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed113    
    PDF Downloaded7    

Recommend this journal