Krammer Heiner, Storr Martin, Madisch Ahmed, Riffel Julia
Gastroenterologie und Ernährungsmedizin, End- und Dickdarmzentrum Mannheim, Germany.
Zentrum für Endoskopie, MVZ Gauting-Starnberg, Germany.
Z Gastroenterol. 2021 Feb;59(2):125-134. doi: 10.1055/a-1340-0204. Epub 2021 Feb 8.
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, 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.
Data on tolerability and effectiveness of LP299V (1 capsule/day; 1 × 10 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.
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.
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.
在临床实践中，肠易激综合征（IBS）的治疗常常具有挑战性。调节肠道微生物群作为一种治疗选择正变得越来越重要。先前在一项为期4周的IBS患者安慰剂对照临床试验中，对一种菌株299v（LP299V）的有效性进行了研究。因此，本非干预性研究的目的是在日常条件下研究LP299V的耐受性和有效性，并获取有关长期治疗的信息。
前瞻性收集了221例IBS患者在25个中心使用LP299V（1粒胶囊/天；1×10CFU）的耐受性和有效性数据。最大治疗持续时间为12周。通过症状日记和医学评估进行调查。将症状的频率和严重程度变化与基线进行比较，并确定主要终点。
在12周的治疗期间，观察到总体症状评分显著且持续降低（p<0.05）。此外，个别症状的严重程度（S）和频率（H）显著降低，如腹痛（S：-67%，H：-51%）、肠胃胀气（S：-61%，H：-63%）、腹泻（S：-70%，H：-32%）和便秘（S：-79%，H：-6%）。紧迫感和排便不尽感显著降低（p<0.001）。此外，生活质量显著提高（心理健康：+110%，对日常生活的影响：-67%，p<0.01）。自我评估表明，94%的患者对LP299V的长期治疗耐受性良好。
在现实生活中，LP299V可显著缓解IBS患者的整体症状。为了达到最大效果，似乎需要长期使用LP299V（如本研究中的12周），且耐受性良好。
