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

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.

Schlüsselwörter

Reizdarmsyndrom - RDS - Langzeittherapie - Probiotika - Mikrobiom

Key words

irritable bowel syndrome - IBS - therapy - probiotics - microbiome

Publication History

Received: 04 September 2020

Accepted: 16 December 2020

Article published online:
08 February 2021

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