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G REEN-LIPPED M USSEL E XTRACT ( P ERNA CANALICULUS) AND G LUCOSAMINE S ULPHATE IN P ATIENTS WITH K NEE O STEOARTHRITIS: T HERAPEUTIC E FFICACY AND E FFECTS.

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Presentation on theme: "G REEN-LIPPED M USSEL E XTRACT ( P ERNA CANALICULUS) AND G LUCOSAMINE S ULPHATE IN P ATIENTS WITH K NEE O STEOARTHRITIS: T HERAPEUTIC E FFICACY AND E FFECTS."— Presentation transcript:

1 G REEN-LIPPED M USSEL E XTRACT ( P ERNA CANALICULUS) AND G LUCOSAMINE S ULPHATE IN P ATIENTS WITH K NEE O STEOARTHRITIS: T HERAPEUTIC E FFICACY AND E FFECTS ON G ASTROINTESTINAL M ICROBIOTA P ROFILES 1 Samantha Coulson, 2 Henry Butt, 3 Phillip Vecchio, 1 Helen Gramotnev, 1 Luis Vitetta 1 The University of Queensland, Centre for Integrative Clinical & Molecular Medicine 2 Bioscreen at Bio21 Molecular Science and Biotechnology Institute and 3 Department of Rheumatology at the Princess Alexandra Hospital, Brisbane QLD Australia Brisbane QLD Australia S CHOOL O F M EDICINE

2 2012 P UBLICATIONS

3 Clinical Trial 1. Green-lipped mussel (Perna canaliculus) extract efficacy in knee osteoarthritis and improvement in gastrointestinal dysfunction: a pilot study Design: Open-label, single group Participants:21 (8 male, 13 female) diagnosed with knee OA, Age (yrs)61.1 ± 12.2 BMI (Kg/m 2 )34.0 ± 9.0 Weight (Kg)96.9 ± 27.1 Waist : Hip ratio 0.9 ± 0.1 Dosage3000 mg day (3 caps b.i.d) Duration8 weeks Outcome measuresLequesne Algofunctional index WOMAC GSRS SF-12v2 TM WOMAC: Western Ontario McMaster Universities Arthritis Index GSRS: Gastrointestinal Symptom Rating Scale

4 R ESULTS

5 The gastrointestinal tract (GIT) comprises a highly complex and not yet fully understood, dense ecosystem of commensal microbiota that is integral to the health of the body as a whole. The gastrointestinal tract (GIT) comprises a highly complex and not yet fully understood, dense ecosystem of commensal microbiota that is integral to the health of the body as a whole. GIT Microbiota & their metabolites: GIT Microbiota & their metabolites: Communicate with the innate and adaptive immune responses locally and systemically through signalling pathways. Communicate with the innate and adaptive immune responses locally and systemically through signalling pathways. These immune-mediated communications also interact with multiple organs such as the gut, liver, muscle and brain, comprising a series of These immune-mediated communications also interact with multiple organs such as the gut, liver, muscle and brain, comprising a series of host-microbe metabolic axes. host-microbe metabolic axes. G ASTROINTESTINAL M ICROBIOTA – M ETABOLISM and I MMUNE R ESPONSES – Nature cover – March 2010 Science. 2012;336(6086):1262-7.

6 Nature June 2011;474:298 I NNATE AND A DAPTIVE I MMUNE M ODULATORS OF THE GIT

7 M USCULOSKELETAL C ONDITIONS – T HE M ICROBIOTA C ONNECTION – Osteoarthritis (OA) is an inflammatory disease of the entire synovial joint: Inflammation is present in OA joints as it is with RA, only to a lesser degree IL-1β, TNF-α, IL-17 Systemic inflammation may disrupt GIT microbiota composition, impair intestinal function and increase intestinal permeability Dysbiosis may induce or further perpetuate inflammation Paracetamol and NSAIDs have shown anti-microbial activity OA patients demonstrate GIT symptoms: reflux, abdominal pain and bloating, altered bowel habits (constipation / diarrhoea) J Rheumatol. 2000;27(6):1373-8World J Gastroenterol. 2010;16(9):1057-62. Am J Gastroenterol. 2008;103(4):872-82.Journal of Parenteral and Enteral Nutrition. 2008;32:648-50. Pharmacol Res. 1994;29(1):89-97.Gut Microbes. 2012;3(4). J Glob Infect Dis. 2010;2(2):105-8.

8 Clinical Trial 2. Green-lipped mussel extract (Perna canaliculus) and glucosamine sulphate in patients with knee osteoarthritis: therapeutic efficacy and effects on gastrointestinal microbiota profiles Cohort Flow Diagram of Patient Recruitment

9 C OMPOSITION AND D ISTRIBUTION OF I NTESTINAL M ICROBIAL G ENERA Ann Med 1990;22:43-8.

10 B ASELINE D EMOGRAPHICS & S CORES

11 Outcomes GLM (n = 21) GS (n = 17) Difference between groups GSRS Change T 0 – T 12 P - 10.4 0.02 - 3.9 0.044 - 6.4 0.162 Lequesne Index Change T 0 - T 12 P - 4.2 < 0.001 - 3.3 0.001 - 0.9 0.5 WOMAC (total) Change T 0 – T 12 P - 18.9 < 0.001 - 14.8 0.001 - 4.1 0.372 WOMAC (pain) Change T 0 – T 12 P - 4.9 < 0.001 - 3.3 0.001 -1.6 0.157 WOMAC (stiffness) Change T 0 – T 12 P - 2.4 < 0.001 - 1.2 < 0.001 - 1.1 0.02 WOMAC (physical) Change T 0 – T 12 P - 11.8 < 0.001 - 10.2 0.001 - 1.6 0.639 M EAN C HANGE IN O UTCOME M EASURES FROM T 0 TO T 12 W EEKS

12 G ASTROINTESTINAL C OMPLAINTS : N UMBER OF P ATIENTS AT T 0 AND T 12 W EEKS AND R ANGE OF S EVERITY A CCORDING TO THE GSRS 7-P OINT LIKERT S CALE

13 GLM groupGS group Organism Baseline Mean (n=21) Week 12 Mean (n=18) p value Baseline Mean (n=17) Week 12 Mean (n=17) p value Normal Range* Total bacterial count 1 x 10 9 – 1 x 10 12 2.31 x 10 10 3.29 x 10 10 0.364.04 x 10 10 3.10 x 10 10 0.72 Total aerobes Coliforms Enterococcus Streptococcus Staphylococcus Yeast 1 x 10 7 – 1 x 10 8 7 x 10 6 – 9 x 10 7 < 5 x 10 5 < 3 x 10 5 < 2 x 10 5 < 1 x 10 4 7.17 x 10 7 4.38 x 10 7 9.32 x 10 6 1.12 x 10 7 4.51 x 10 6 9.49 x 10 3 8.83 x 10 7 5.82 x 10 7 5.75 x 10 6 2.84 x 10 7 1.97 x 10 4 3.46 x 10 3 0.71 0.68 0.48 0.35 1.00 0.13 6.98 x10 7 6.01x 10 7 4.86 x 10 6 1.76 x 10 7 7.03 x 10 5 3.85 x 10 3 1.02 x 10 8 7.52 x 10 7 8.41 x 10 6 2.98 x 10 7 4.78 x 10 4 3.92 x 10 5 0.35 0.77 0.64 0.83 0.36 0.75 Total anaerobes Bacteroides Eubacterium Lactobacillus Bifidobacterium Clostridium 1 x 10 8 – 1 x 10 12 9 x 10 7 – 9.5 x10 11 < 1 x 10 9 5 x 10 5 – 1 x 10 7 5 x 10 5 – 5 x 10 8 <5 x 10 8 2.30 x 10 10 1.31 x 10 10 6.36 x 10 9 8.06 x 10 8 3.83 x 10 9 1.91 x 10 9 3.28 x 10 10 1.82 x 10 10 1.24 x 10 10 8.44 x 10 8 4.19 x 10 9 8.11 x 10 8 0.35 0.23 0.39 0.75 0.51 0.70 4.03 x 10 10 3.05 x 10 10 5.02 x 10 9 1.87 x 10 8 7.75 x 10 9 1.84 x 10 9 3.09 x 10 10 1.98 x 10 10 7.60 x 10 9 8.27 x 10 8 5.58 x 10 9 9.95 x 10 8 0.74 0.27 0.25 0.76 0.24 0.94 * Bioscreen data from normal, healthy population

14 SFB as a cluster member of the Clostridia sp. reported to trigger T cell driven intestinal inflammation and arthritis Serum amyloid ATGF-β secretion Clostridium-related bacteria Soluble factor Bacterial polysaccharide A Segmented filamentous Bacteria (SFB) Clostridium sp. Adherent Faecalibacterium prausnitzii Bacteroides fragilis Intestinal epithelium Intestinal lumen GI tissue and Blood Vessels Myeloid cell T H 17 T reg TLR2+ cell T H 17 accumulation T reg accumulation (IL-10 production) ? unknown Science 2011;331:289 Inflamm Bowel Dis 2007;13:1202 Immunity 2010;32:815

15 Our cohort of knee OA patients demonstrated GIT dysbiosis and GIT dysfunction Our cohort of knee OA patients demonstrated GIT dysbiosis and GIT dysfunction GIT microbiota play a critical role in maintaining immune homeostasis and inflammatory regulation GIT microbiota play a critical role in maintaining immune homeostasis and inflammatory regulation GIT dysbiosis may play a significant role in the aetiopathogenesis of OA GIT dysbiosis may play a significant role in the aetiopathogenesis of OA Re-regulation of GIT microbiota by Green-Lipped Mussel extract and Glucosamine Sulphate may elude to a mechanism of action for their therapeutic efficacy Re-regulation of GIT microbiota by Green-Lipped Mussel extract and Glucosamine Sulphate may elude to a mechanism of action for their therapeutic efficacy C ONCLUSION T HE GIT IS O FTEN A F ORGOTTEN O RGAN WHEN C ONSIDERING THE P ATHOGENESIS OF M USCULOSKELETAL D ISEASE

16 A CKNOWLEDGEMENTS L UIS V ITETTA P HILLIP V ECCHIO (Rheumatologist PA Hospital) H ENRY B UTT (Bioscreen) M ICHAEL W HITEHOUSE P AUL M ASCI


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