Z Gastroenterol 2021; 59(02): 125-134
DOI: 10.1055/a-1340-0204
Originalarbeit

Reizdarmbehandlung mit Lactobacillus plantarum 299v: Längere Einnahme verstärkt Behandlungserfolg – Ergebnisse einer nichtinterventionellen Studie

Treatment of IBS with Lactobacillus plantarum 299v: Therapeutic success increases with length of treatment – real-life data of a non-interventional study in Germany
Heiner Krammer
1   Gastroenterologie und Ernährungsmedizin, End- und Dickdarmzentrum Mannheim, Germany
,
Martin Storr
2   Zentrum für Endoskopie, MVZ Gauting-Starnberg, Germany
,
Ahmed Madisch
3   Klinik für Gastroenterologie, interventionelle Endoskopie, Diabetologie und Akutgeriatrie, KRH Klinikum Siloah, Hannover, Germany
,
Julia Riffel
4   Institut für Radiologie, Universitätsmedizin Mannheim, Germany
› Author Affiliations
Supported by: Microbiotica GmbH

Zusammenfassung

Einleitung Die Behandlung des Reizdarmsyndroms (RDS) ist in der Praxis oft eine Herausforderung. Als Therapieoption gewinnt die Modulation des Darmmikrobioms dabei immer mehr an Bedeutung. Die Wirksamkeit des Bakterienstamms Lactobacillus plantarum 299v (LP299V) wurde bei Reizdarmpatienten bereits in mehreren placebokontrollierten Studien über 4 Wochen gezeigt. Ziel der im Folgenden beschriebenen nichtinterventionellen Studie war es, die Verträglichkeit und Wirksamkeit von LP299V unter Praxisbedingungen zu untersuchen und neue Erkenntnisse über einen längeren Einnahmezeitraum zu gewinnen.

Methodik In 25 Zentren wurden prospektiv Daten von 221 RDS-Patienten zur Verträglichkeit und Wirksamkeit von LP299V (1 Kapsel/Tag; 1 × 1010 KBE) über eine maximale Beobachtungsdauer von 12 Wochen erhoben. Die Erhebung erfolgte mittels Reizdarmtagebüchern und ärztlicher Dokumentation bei den Studienvisiten. Die Veränderung von Häufigkeit und Schweregrad der Beschwerden gegenüber der Baseline wurde als primärer Endpunkt festgelegt.

Ergebnisse Im Verlauf der 12-wöchigen Behandlung kam es zu einer signifikanten und kontinuierlichen Reduktion der Gesamtsymptomatik (p < 0,05). Darüber hinaus kam es zu einer signifikanten Reduktion von Schwere (S) und Häufigkeit (H) einzelner Symptome, wie Abdominalschmerz (S: – 67 %, H: – 51 %), Flatulenz (S: – 61 %, H: – 63 %), Diarrhoe (S: – 70 %, H: – 32 %) und Obstipation (S: – 79 %, H: – 6 %). Das Gefühl der dringlichen und unvollständigen Entleerung sank ebenfalls signifikant (p < 0,001). Die Lebensqualität der Patienten stieg signifikant an (seelisches Wohlbefinden: + 110 %, negativer Einfluss auf den Alltag: – 67 %, p < 0,01). Die Langzeitbehandlung mit LP299V wurde von 94 % der Patienten als gut verträglich bewertet.

Diskussion LP299V konnte die Gesamtbeschwerden von RDS-Patienten unter deutschen Alltagsbedingungen signifikant bessern. Um einen größeren Effekt zu erzielen, ist eine längerfristige Einnahme von LP299V (hier 12 Wochen) sinnvoll; die Verträglichkeit ist in diesem Zeitraum gut.

Abstract

Introduction The treatment of irritable bowel syndrome (IBS) in clinical practice is frequently challenging. Modulation of the intestinal microbiome as a treatment option is becoming more and more important. The effectiveness of a bacterial strain, Lactobacillus plantarum 299v (LP299V), was previously investigated in placebo-controlled clinical trials in patients with IBS over 4 weeks. The aims of the present non-interventional study were therefore to investigate tolerability and effectiveness of LP299V under everyday conditions and to gain information on long-term treatment.

Methods Data on tolerability and effectiveness of LP299V (1 capsule/day; 1 × 1010 CFU) were prospectively collected in 25 centers in 221 patients with IBS. The maximal treatment duration was 12 weeks. The survey was carried out using symptom diaries and medical assessments. Changes in frequency and severity of symptoms were compared to baseline and defined the primary endpoint.

Results During the 12-week treatment, a significant and continuous reduction of overall symptom score (p < 0.05) was observed. In addition, a significant reduction of severity (S) and frequency (H) of individual symptoms, such as abdominal pain (S: – 67 %, H: – 51 %), flatulence (S: – 61 %, H: – 63 %), diarrhea (S: – 70 %, H: – 32 %) and constipation (S: – 79 %, H: – 6 %) was observed. Urgency and feeling of incomplete evacuation were significantly decreased (p < 0.001). Additionally, quality of life increased significantly (mental well-being: + 110 %, influence on everyday life: –67 %, p < 0.01). Self-assessment identified that long-term treatment with LP299V was tolerated well by 94 % of patients.

Conclusion In real life, LP299V significantly alleviates the global symptoms of IBS in patients. In order to achieve the maximum effect, long-term use of LP299V (as here 12 weeks) appears to be indicated and is well tolerated.



Publication History

Received: 04 September 2020

Accepted: 16 December 2020

Article published online:
08 February 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
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  • Literatur

  • 1 Layer P, Andresen V, Pehl C. et al [Irritable bowel syndrome: German consensus guidelines on definition, pathophysiology and management]. Z Gastroenterol 2011; 49: 237-293 . doi:10.1055/s-0029-1245976
  • 2 Beckh KKH, Lankisch PG, Mayerle J. et al 4.12 Reizdarmsyndrom (RDS). In: Koop I. ed Gastroenterologie compact. 3 vollständig überarbeitete und aktualisierte Auflage ed.. Stuttgart: Georg Thieme Verlag; 2013. DOI: 10.1055/b-0034-61728
  • 3 Corsetti M, Whorwell P. The global impact of IBS: time to think about IBS-specific models of care?. Therap Adv Gastroenterol 2017; 10: 727-736 . doi:10.1177/1756283x17718677
  • 4 Layer P, Andresen V, Allescher H. et al S3-Leitlinie „Reizdarmsyndrom“ als Konsultationsfassung. Im Internet (Stand 28.06.2020): https://www.dgvs.de/wp-content/uploads/2020/06/Leitlinie-LL-RDS_19.06.20_Konsulationsfassung.pdf
  • 5 Distrutti E, Monaldi L, Ricci P. et al Gut microbiota role in irritable bowel syndrome: New therapeutic strategies. World J Gastroenterol 2016; 22: 2219-2241 . doi:10.3748/wjg.v22.i7.2219
  • 6 Quigley EM, Fried M, Gwee KA. et al World Gastroenterology Organisation Global Guidelines Irritable Bowel Syndrome: A Global Perspective Update September 2015. J Clin Gastroenterol 2016; 50: 704-713 . doi:10.1097/mcg.0000000000000653
  • 7 National Collaborating Centre for N, Supportive C. National Institute for Health and Care Excellence: Clinical Guidelines. In Irritable bowel syndrome in adults: diagnosis and management. London: National Institute for Health and Care Excellence (UK) Copyright © NICE 2018; 2017
  • 8 Ducrotté P, Sawant P, Jayanthi V. Clinical trial: Lactobacillus plantarum 299v (DSM 9843) improves symptoms of irritable bowel syndrome. World J Gastroenterol 2012; 18: 4012-4018 . doi:10.3748/wjg.v18.i30.4012
  • 9 Johansson ML, Nobaek S, Berggren A. et al Survival of Lactobacillus plantarum DSM 9843 (299v), and effect on the short-chain fatty acid content of faeces after ingestion of a rose-hip drink with fermented oats. Int J Food Microbiol 1998; 42: 29-38 . doi:10.1016/s0168-1605(98)00055-5
  • 10 Nobaek S, Johansson ML, Molin G. et al Alteration of intestinal microflora is associated with reduction in abdominal bloating and pain in patients with irritable bowel syndrome. Am J Gastroenterol 2000; 95: 1231-1238 . doi:10.1111/j.1572-0241.2000.02015.x
  • 11 Niedzielin K, Kordecki H, Birkenfeld B. A controlled, double-blind, randomized study on the efficacy of Lactobacillus plantarum 299V in patients with irritable bowel syndrome. Eur J Gastroenterol Hepatol 2001; 13: 1143-1147 . doi:10.1097/00042737-200110000-00004
  • 12 Bengtsson M, Ohlsson B, Ulander K. Development and psychometric testing of the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS). BMC Gastroenterol 2007; 7: 16 . doi:10.1186/1471-230x-7-16
  • 13 Passos MC, Lembo AJ, Conboy LA. et al Adequate relief in a treatment trial with IBS patients: a prospective assessment. Am J Gastroenterol 2009; 104: 912-919 . doi:10.1038/ajg.2009.13
  • 14 Madisch A, Labenz C, Hollenz M. et al [Therapeutic management of irritable bowel syndrome in the family doctor's practice – probiotics and phytotherapeutics are often used successfully]. MMW Fortschr Med 2020; 162: 7-13 . doi:10.1007/s15006-020-0658-6
  • 15 Guglielmetti S, Mora D, Gschwender M. et al Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life – a double-blind, placebo-controlled study. Aliment Pharmacol Ther 2011; 33: 1123-1132 . doi:10.1111/j.1365-2036.2011.04633.x
  • 16 Andresen V, Gschossmann J, Layer P. Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001) in the treatment of irritable bowel syndrome: a multicentre, randomised, double-blind, placebo-controlled clinical trial. Lancet Gastroenterol Hepatol 2020; 5: 658-666 . doi:10.1016/s2468-1253(20)30056-x
  • 17 Miller LE. Study design considerations for irritable bowel syndrome clinical trials. Ann Gastroenterol 2014; 27: 338-345
  • 18 Gordon S, Ameen V, Bagby B. et al Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy. Dig Dis Sci 2003; 48: 1317-1323 . doi:10.1023/a:1024159226274
  • 19 Pop LL, Mureşan IA, Dumitraşcu DL. How much bloating in the irritable bowel syndrome?. Rom J Intern Med 2018; 56: 221-226 . doi:10.2478/rjim-2018-0017
  • 20 Principi N, Cozzali R, Farinelli E. et al Gut dysbiosis and irritable bowel syndrome: The potential role of probiotics. J Infect 2018; 76: 111-120 . doi:10.1016/j.jinf.2017.12.013
  • 21 Ford AC, Moayyedi P. Meta-analysis: factors affecting placebo response rate in the irritable bowel syndrome. Aliment Pharmacol Ther 2010; 32: 144-158 . doi:10.1111/j.1365-2036.2010.04328.x
  • 22 Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol 2012; 10: 712-721.e714 . doi:10.1016/j.cgh.2012.02.029
  • 23 Palsson OS, Whitehead WE, van Tilburg MA. et al Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology 2016; DOI: 10.1053/j.gastro.2016.02.014.
  • 24 Stölting P. Obstipationsprädominanter Reizdarmund chronische Obstipation. Ars Med 2012; 21: 1177-1181
  • 25 Siah KT, Wong RK, Whitehead WE. Chronic Constipation and Constipation-Predominant IBS: Separate and Distinct Disorders or a Spectrum of Disease?. Gastroenterol Hepatol (N Y) 2016; 12: 171-178
  • 26 Chen HD, Bair MJ, Chang WC. et al Similarities and differences between IBS-C and FC with regards to symptomatology, sleep quality and psychological attributes. J Formos Med Assoc 2020; 119: 75-80 . doi:10.1016/j.jfma.2019.02.017
  • 27 Bellini M, Gambaccini D, Usai-Satta P. et al Irritable bowel syndrome and chronic constipation: Fact and fiction. World J Gastroenterol 2015; 21: 11362-11370 . doi:10.3748/wjg.v21.i40.11362
  • 28 Grobe TG, Steinmann S, Szecsenyi J. Barmer-Arztreport 2019 – Das Volksleiden Reizdarmsyndrom wird oft falsch behandelt. Köln: BARMER; 2019
  • 29 Sloan TJ, Jalanka J, Major GAD. et al A low FODMAP diet is associated with changes in the microbiota and reduction in breath hydrogen but not colonic volume in healthy subjects. PLoS One 2018; 13: e0201410 . doi:10.1371/journal.pone.0201410
  • 30 Zia JK, Barney P, Cain KC. et al A Comprehensive Self-Management Irritable Bowel Syndrome Program Produces Sustainable Changes in Behavior After 1 Year. Clin Gastroenterol Hepatol 2016; 14: 212-219.e211-212 . doi:10.1016/j.cgh.2015.09.027
  • 31 Heitkemper M, Carter E, Ameen V. et al Women with irritable bowel syndrome: differences in patients’ and physicians’ perceptions. Gastroenterol Nurs 2002; 25: 192-200 . doi:10.1097/00001610-200209000-00004
  • 32 Ballou S, Beath A, Kaptchuk TJ. et al Factors Associated With Response to Placebo in Patients With Irritable Bowel Syndrome and Constipation. Clin Gastroenterol Hepatol 2018; 16: 1738-1744.e1731 . doi:10.1016/j.cgh.2018.04.009
  • 33 Brown JP, Wing K, Evans SJ. et al Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017. BMJ Open 2019; 9: e028133 . doi:10.1136/bmjopen-2018-028133
  • 34 Niknam R, Mousavi S, Safarpour A. et al Self-medication of irritable bowel syndrome and dyspepsia: How appropriate is it?. J Res Pharm Pract 2016; 5: 121-125 . doi:10.4103/2279-042x.179576
  • 35 Transplantation ESfBaM. Non-interventional Prospective Studies. Im Internet (Stand 26.08.2020): https://www.ebmt.org/non-interventional-prospective-studies