Gastroenterology Today Summer 2019

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FEATURE SHOWING THE TRUE VALUE OF PROBIOTICS – UNDERSTANDING THE SCIENCE AND HISTORY IS KEY Written by Mike Butler, CEO, Symprove Therapeutic use of probiotics isn’t new. The use of fermented foods to improve intestinal health has been recorded back thousands of years, a long time before there was an ounce of understanding of the gut microbiome and the importance of its managment. 1 The Russian scientist Eli Metchnikoff (generally believed to be the ‘father of probiotics’) first hypothesised that lactic acid bacteria provided either a type of protection from, or reversal of, intestinal auto-intoxication. He won the Nobel Prize in medicine in 1908 by demonstrating harmful microbes can be replaced by beneficial microbes to treat intestinal illnesses. His regimen became sour milk in the hope of populating his digestive tract with Bulgarian bacillus (Lactobacillus bulgaricus) – the first use of ‘probiotics’ as a dietary supplement. Mehcnikoff laid the foundations for faecal transplantation, predicted the existence of bacterial translocation from the intestinal lumen into the bloodstream and lymphatic system and theories linking chronic inflammation with atherosclerosis. 2 As our knowledge of the gut microbiome has grown, so has our scepticism of probiotics. Some of this scepticism is fair, some not so, as we bucket a group of probiotics which come in various different shapes and sizes and treat them as equal. This is just not the case as there are various formulations, bacterial strains, mode of delivery and impact on microbiota to consider. 3 So what do we need to do to change perceptions and show the value of probiotics? Firstly, we need to be brave like Mehcnikoff and explore the Health Diagnostics for Digestive Health Management Meet the experts at BSG on stand no. 42 SEC Glasgow, 17 th -20 th June Faecal Immunochemical Testing (FIT) for Bowel Cancer Screening or Symptomatic Assessment 2021.12.31 H 999123 g Name 80101274 Date of Sample GASTROENTEROLOGY TODAY - SUMMER 2019 Calprotectin Testing Point of Care and Remote Patient Management Solutions Therapeutic Drug Monitoring New Quantum Blue ® Rapid Test for anti-TNFα Therapeutic Drug Monitoring Tel: 023 8048 3000 | Web: www.alphalabs.co.uk M / F 14 DDH+BSG-2019_FINAL_13May19.indd 1 13/05/2019 16:30:55
FEATURE possibilities of human health beyond our existing beliefs. Our gut microbiota contains tens of trillions of micro-organisms, including at least 1,000 different species of known bacteria with more than 3 million genes (150 times more than human genes). To put it in perspective, the Human Genome Project took 15 years to complete so we inevitably have far more to understand about the makeup of the gut microbiome. However, already we are seeing positive results for some probiotics in improving people’s health. It will take time to know the exact potential of probiotics work and also our understanding of the gut microbiome, its full role and where it can be adapted to improve lives, but we are working with safe food supplements which allow us to be braver with their application. LUTATHERA ® ▼ LUTETIUM ( 177 Lu) OXODOTREOTIDE Secondly, the balance between science driven and commercial goals needs to be heavily weighted towards the former. As probiotics are a safe food supplement, it is easy for some to focus on market penetration and not mode of action. However, if we are going to realise the potential of probiotics, an evidence based, long-term approach needs to be undertaken for all manufacturers of probiotics. By following the science, there is a real possibility that we might find something that is ‘game-changing’. This is already a growing appetite to push our current perceptions, understanding and application of probiotics. For example, trials are now looking at the link between the microbiome Parkinson’s and the gut brain-axis. 4 As we continue to learn about the different ‘good’ bacteria, the way they arrive in the gut in an alive state, survive hostile gastric conditions and thrive in the colon, we will get a better understanding of this complex microsystem that is living inside all of us. Ten years from now, I am confident that we will be looking back at today as the cusp of a revolution, one in which the science-led probiotics will have an important part to play. References: 1. Ozen M and Dinleyici EC. The history of probiotics: the untold story. Benef Microbes. 2015;6(2):159-65. 2. Mackowiak PA. Recycling Metchnikoff: Probiotics, the Intestinal Microbiome and the Quest for Long Life. Front Public Health. 2013; 1: 52. 3. Gaisford S. et al. Comparative survival of commercial probiotic formulations: Tests in biorelevant gastric fluids and real-time measurements using microcalorimetry. Beneficial Microbes 6(1): 1-11 · October 2014 4. Chaudhuri R. Kings Colledge London. Oral Symprove (a probiotic) for the management of motor and non-motor symptoms in people with Parkinson’s: a novel randomised, double-blind, placebo-controlled pilot study. Lutathera ® ▼ lutetium ( 177 Lu) oxodotreotide is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults. www.lutathera.com Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Advanced Accelerator Applications at: pharmacovigilance@adacap.com pv@imagingequipment.co.uk Tel: 33 (0) 785 61 90 66, Switchboard +334 50 99 30 70, Fax +334 50 99 30 71 Prescribing Information; Lutathera 370 MBq/mL solution for infusion. Lutetium ( 177 Lu) oxodotreotide Presentation: Solution for infusion. Clear, colourless to slightly yellow solution. One mL of solution contains 370 MBq of lutetium ( 177 Lu) oxodotreotide at the date and time of calibration. The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion. Uses: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults. Administration: Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of the patient by a qualified physician. Before starting treatment with Lutathera, somatostatin receptor imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake (tumour uptake score ≥ 2). Additionally before each administration and during the treatment, tests are required to re assess the patient’s condition and adapt the therapeutic protocol if necessary (dose, infusion interval, number of infusions). See SmPC for further details. The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each. The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT). For renal protection purpose, an amino acid solution must be administered intravenously. See SmPC for further details. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion. Lutathera must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly with amino acid solution administered by contralateral intravenous infusion (separate intravenous catheter and initiated 30 minutes prior to Lutathera). This medicinal product must not be injected as a bolus. Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion. The recommended infusion method for administration of Lutathera is the gravity method. During the administration the recommended precaution measures should be undertaken. Lutathera should be infused directly from its original container. The vial must not be opened or the solution transferred to another container. During the administration only disposable materials should be used. The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion. See SmPC for further details of storage, room and equipment requirements, as well as detailed administration procedure. In some circumstances, it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after the first administration or discontinue the treatment. General Warnings: Contraindications include hypersensitivity to the active substance, to any of the excipients, established or suspected pregnancy or when pregnancy has not been excluded, kidney failure with creatinine clearance < 30 mL/min. Special precautions should be taken where patients have renal or urinary tract morphological abnormalities, urinary incontinence, mild to moderate chronic kidney disease with creatinine clearance ≥ 50 mL/min, haematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia, bone metastasis or have had previous chemotherapy. Late-onset myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with Lutathera, factors such as age >70 years, impaired renal function, baseline cytopenias, prior number of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior radiotherapy are suggested as potential risks and/or predictive factors. Crises due to excessive release of hormones or bioactive substances may occur and overnight hospitalisation should be considered for vulnerable patients. Radioprotection rules should be followed including special care in the event of extravasation and urinary incontinence, see SmPC for full details or radio protective measures. The product contains up to 3.5 mmol sodium and this should be considered in patients on a sodium controlled diet. Undesirable effects: Common side effects include bone marrow toxicity with thrombocytopenia, lymphopenia, anaemia or pancytopenia. Nephrotoxicity with haematuria, renal failure, proteinuria. Blood creatinine increased, nausea, vomiting, fatigue, QT prolonged, hypertension, flushing, hypotension, dyspnoea, abdominal distension, diarrhoea, abdominal pain, constipation, dyspepsia, gastritis, hyperbilirubinaemia, alopecia, musculoskeletal pain, muscle spasms, acute kidney injury, increased LFTs. Marketing Authorisation Holder: Advanced Accelerator Applications 20 rue Diesel 01630 Saint Genis Pouilly France Marketing Authorisation Number EU/1/17/1226/001 Legal Category: POM Price: £17,875 per vial Date of preparation of PI: October 2017 Date of preparation: May 2019 Job ID Number: AAA.Lu177-UKI-0013 AAA-Lu177-GL-0028 GASTROENTEROLOGY TODAY - SUMMER 2019 15
Page 1 and 2: Volume 29 No. 2 Summer 2019 Gastroe
Page 3 and 4: CONTENTSMatthew’s Perspective: 5
Page 5 and 6: EDITORS COMMENT EDITORS COMMENT See
Page 7 and 8: CASE REPORT You’ve probably never
Page 9 and 10: Life feels good when they’re unde
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