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[Treatment of IBS with Lactobacillus plantarum 299v: Therapeutic success increases with length of treatment - real-life data of a non-interventional study in Germany].

  • 2021-02
  • Zeitschrift fur Gastroenterologie 59(02)
    • Heiner Krammer
    • Martin Storr
    • Ahmed Madisch
    • Julia Riffel

Study Design

Type
Observational
Sample size
n = 221
Population
221 patients with IBS
Methods
Prospectively collected data on tolerability and effectiveness of LP299V (1 capsule/day; 1 × 10^10 CFU) in 25 centers; maximal treatment duration was 12 weeks; survey carried out using symptom diaries and medical assessments; changes in frequency and severity of symptoms were compared to baseline

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.

Research Insights

Adverse Events Reported

  • Lactobacillus plantarum 299v→Overall tolerability

    Self-assessment identified that long-term treatment with LP299V was tolerated well by 94 % of patients.

    Finding
    Reported
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