A Randomized, Double-blind Placebo-controlled Trial to Improve Clinical Indicators in a Population with Functional Constipation. Constipation and Microbiome

In this randomized, double-blind, and placebo-controlled study, the effects of the test food, ID-HWS1000, composed of Lactobacillus and Bifidobacterium species, xylooligosaccharide polymers, and various sources of dietary fiber, were studied to see whether they improve bowel activity or cause changes in the gut microbiome. Thirty adult males and females with “functional constipation” according to the Rome III criteria, were randomly assigned to two groups, 20 participants in the ID-HWS1000 group and 10 in the placebo group. The test or control foods were consumed for four weeks. To assess the improvement in bowel activity, clinical data and gut microbiome analyses were conducted before and after food intake. There were significant differences between the groups in response to 9 of the 12 questions (namely the number and duration of bowel movements, amount of feces, number of irritant bowel movements, number of times bowel movements felt incomplete, shape of the feces, amount of gas in the gut, discomfort after defecation, and discomfort due to constipation) (P<0.05). Gut microbiome analyses showed decreased Firmicutes (Ruminococcaceae and Lachnospiraceae) and increased Bacteroidetes (Bacteroidaceae) (P<0.05). Moreover, ID-HWS1000 directly improved the ‘discomfort’ associated with bowel movements and indirectly decreased Lachnospiraceae, conversely increasing Bacteroidaceae. These results confirmed that multiple prescriptions of ID-HWS1000 improve bowel activity in patients with functional constipation and have a positive effect on changes in the gut microbiome in these patients.

本研究为随机、双盲、安慰剂对照试验，旨在评估由乳杆菌属（Lactobacillus）、双歧杆菌属（Bifidobacterium）菌株、低聚木糖聚合物及多种膳食膳食纤维来源构成的受试食品ID-HWS1000，能否改善肠道活动或引发肠道菌群结构改变。本研究共招募30名符合罗马Ⅲ（Rome III）标准的功能性便秘成年男女受试者，按随机原则分为两组：ID-HWS1000组20人，安慰剂组10人。受试者连续服用受试食品或对照食品共4周。为评估肠道活动改善情况，本研究在受试食品摄入前后分别采集临床数据并开展肠道菌群分析。两组受试者在12项评价问题中有9项的应答存在显著差异（P<0.05），具体包括排便次数、排便时长、粪便量、刺激性排便次数、排便不尽感次数、粪便性状、肠道气体量、排便后不适及便秘相关不适。肠道菌群分析结果显示，厚壁菌门（Firmicutes）下属的瘤胃球菌科（Ruminococcaceae）与毛螺菌科（Lachnospiraceae）丰度显著降低，拟杆菌门（Bacteroidetes）下属的拟杆菌科（Bacteroidaceae）丰度显著升高（P<0.05）。此外，ID-HWS1000可直接改善排便相关不适，并通过间接降低毛螺菌科丰度、提升拟杆菌科丰度调节肠道菌群结构。本研究结果证实，规律摄入ID-HWS1000可改善功能性便秘患者的肠道活动，并对该类患者的肠道菌群结构变化产生积极影响。