Complife Group, Parc Cientı́fic de Barcelona (Edifici Clúster), Avinguda Doctor Marañón, 08028 Barcelona, Spain.
Universitat Internacional de Catalunya, Faculty of Economics and Social Sciences, 08017 Barcelona, Spain.
Benef Microbes. 2024 Sep 5;15(6):679-688. doi: 10.1163/18762891-bja00038.
Treatment with probiotics can help manage chronic constipation by softening the stools and possibly acting synergistically with front-line treatments. We assessed the efficacy of Bifidobacterium animalis subsp. lactis BLa80 in maltodextrin as a food supplement in regulating the intestinal habit of subjects with chronic constipation with type 1 or 2 stools on the Bristol scale index and/or less than three stools per week. A multicentre, randomised, double-blind, placebo-controlled clinical trial was carried out in subjects aged 18 and over with chronic constipation. The study enrolled forty-six subjects who were randomised one-to-one to receive the potential probiotic in maltodextrin (n = 23) or a placebo (n = 23). Investigators assessed changes in intestinal habits by analysing the mean number of weekly stools and the stool types according to the Bristol Scale. Patients reported constipation symptoms with PAC-SYM (patient assessment of constipation - symptoms), and the impact on quality of life with PAC-QoL (patient assessment of constipation - quality of life) and GI-QLI (gastrointestinal quality of life index). Patients on the intervention group showed a greater tendency to normalise the type of stools than those in the placebo group. This difference towards regular stool types (type 3 and 4) was statistically significant at weeks 8 and 12 relative to week 4 (P-values = 0.006 and 0.027, respectively). The proportion of constipated patients in the experimental group dropped over time, while the rate slightly increased in the placebo group in a statistically significant manner at week 12 relative to week 4 ( P = 0.037). Overall, the present study shows oral intake of B. animalis subsp. lactis BLa80 in maltodextrin for 12 weeks improves intestinal habits in subjects with chronic constipation. Our study provides evidence to the efficacy and safety use of this formulation as an effective tool for improving stool consistency in constipated patients. The trial was registered at ClinicalTrials.gov: NCT05980988.
双歧杆菌亚种。乳杆菌 BLa80 在麦芽糊精中的应用作为一种食品补充剂，用于调节慢性便秘患者的肠道习惯，这些患者的粪便类型为布里斯托分类指数 1 型或 2 型，或每周排便次数少于 3 次。在年龄在 18 岁及以上的慢性便秘患者中进行了一项多中心、随机、双盲、安慰剂对照的临床试验。研究纳入了 46 名慢性便秘患者，他们被随机分为一组，一组接受潜在益生菌（n=23），一组接受安慰剂（n=23）。研究人员通过分析每周排便次数和粪便类型来评估肠道习惯的变化，粪便类型按照布里斯托分类指数进行评估。患者使用 PAC-SYM（患者便秘症状评估量表）报告便秘症状，使用 PAC-QoL（患者便秘生活质量评估量表）和 GI-QLI（胃肠道生活质量指数）评估对生活质量的影响。干预组患者的粪便类型更倾向于正常化，而安慰剂组则没有。与第 4 周相比，第 8 周和第 12 周时，实验组向正常粪便类型（3 型和 4 型）的转变具有统计学意义（P 值分别为 0.006 和 0.027）。实验组中便秘患者的比例随着时间的推移而下降，而安慰剂组中便秘患者的比例则在第 12 周时相对于第 4 周呈统计学意义的上升（P=0.037）。总的来说，本研究表明，口服双歧杆菌亚种。乳杆菌 BLa80 在麦芽糊精中持续 12 周可改善慢性便秘患者的肠道习惯。我们的研究为该配方的疗效和安全性提供了证据，证明它是一种有效的工具，可改善便秘患者的粪便稠度。该试验在 ClinicalTrials.gov 上注册：NCT05980988。
