富含菊粉和维生素的康普茶饮品治疗女性便秘型肠易激综合征的疗效评估：一项随机试点研究。
Evaluation of the Efficacy of Kombucha-Based Drink Enriched with Inulin and Vitamins for the Management of Constipation-Predominant Irritable Bowel Syndrome in Females: A Randomized Pilot Study.
作者信息
Isakov Vasily A, Pilipenko Vladimir I, Vlasova Alina V, Kochetkova Alla A
机构信息
Department of Gastroenterology & Hepatology, Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia.
Laboratory of Food Biotechnology and Foods for Special Dietary Uses, Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia.
出版信息
Curr Dev Nutr. 2023 Nov 24;7(12):102037. doi: 10.1016/j.cdnut.2023.102037. eCollection 2023 Dec.
BACKGROUND
Constipation-predominant irritable bowel syndrome (IBS-C) mainly affects females, and dietary interventions for symptom relief often yield poor results because of low patient adherence. The development of functional food products enriched with dietary fibers may increase patients' adherence to a healthy diet and relieve IBS-С symptoms.
OBJECTIVE
This proof-of-concept, open-label, randomized controlled pilot study is aimed to evaluate the efficacy of kombucha enriched with inulin and vitamins in females with IBS-C.
METHODS
Forty females with IBS-C were randomly assigned to receive either 220 mL of kombucha enriched with inulin (2.53 g/220 mL) and vitamins (B1 - 0.59 mg, B2 - 0.55 mg, B3 - 5.9 mg, B6 - 0.7 mg, and folic acid - 81.4 μg/220 mL) or water for 10 d. Stool frequency, Bristol stool scale score (BSSS), and abdominal symptoms were evaluated using a 5-point Likert scale on days 5, 9 and 14 of the study. The palatability of the drink was assessed using a visual analog scale.
RESULTS
After 10 d, the kombucha group showed a significant increase in stool frequency (0.60 ± 0.31-0.85 ± 0.19 times/d; 0.004) compared with the control (0.63 ± 0.33 compared with 0.72 ± 0.28; = 0.6). The mean values of the BSSS increased in the kombucha group (3.0 ± 1.2-4.4 ± 1.0; 0.001), whereas they remained unchanged in the control (2.9 ± 1.2 compared with 3.4 ± 1.2; 0.6). The kombucha group also experienced a significant decrease in the feeling of incomplete bowel emptying (1.88 ± 0.78 compared with 1.41 ± 0.56 points; 0.015), which was not observed in the control group.
CONCLUSIONS
Short-term consumption of kombucha enriched with inulin and vitamins was associated with an increase in stool frequency, an improvement in the BSSS, and a reduction in the feeling of incomplete bowel emptying in females with IBS-C. Further large-scale clinical trials investigating the efficacy of kombucha enriched with inulin and vitamins in patients with IBS-C are warranted to prove the observed effects.
TRIAL REGISTRATION NUMBER
This trial was registered at clinicaltrials.gov as NCT05164861 (==https://clinicaltrials.gov/study/NCT05164861?term=NCT05164861&rank=1; registered on 18 December, 2021).
背景
以便秘为主的肠易激综合征（IBS-C）主要影响女性，由于患者依从性低，通过饮食干预缓解症状的效果往往不佳。开发富含膳食纤维的功能性食品可能会提高患者对健康饮食的依从性，并缓解IBS-C症状。
目的
本概念验证、开放标签、随机对照试验旨在评估富含菊粉和维生素的康普茶对IBS-C女性患者的疗效。
方法
40名IBS-C女性患者被随机分配，分别接受220毫升富含菊粉（2.53克/220毫升）和维生素（B1 - 0.59毫克、B2 - 0.55毫克、B3 - 5.9毫克、B6 - 0.7毫克、叶酸 - 81.4微克/220毫升）的康普茶或水，为期10天。在研究的第5天、第9天和第14天，使用5级李克特量表评估排便频率、布里斯托大便分类法评分（BSSS）和腹部症状。使用视觉模拟量表评估饮料的适口性。
结果
10天后，与对照组相比，康普茶组的排便频率显著增加（从0.60±0.31次/天增加到0.85±0.19次/天；P = 0.004）（对照组从0.63±0.33次/天增加到0.72±0.28次/天；P = 0.6）。康普茶组的BSSS平均值增加（从3.0±1.2增加到4.4±1.0；P = 0.001），而对照组保持不变（从2.9±1.2增加到3.4±1.2；P = 0.6）。康普茶组的排便不尽感也显著降低（从1.88±0.78分降至1.41±0.56分；P = 0.015），而对照组未观察到这一变化。
结论
短期饮用富含菊粉和维生素的康普茶与IBS-C女性患者排便频率增加、BSSS改善以及排便不尽感减轻有关。有必要进一步开展大规模临床试验，研究富含菊粉和维生素的康普茶对IBS-C患者的疗效，以证实所观察到的效果。
试验注册号
本试验在clinicaltrials.gov注册，注册号为NCT05164861（==https://clinicaltrials.gov/study/NCT05164861?term=NCT05164861&rank=1；于2021年12月18日注册）。
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