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

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.