Abstract
Constipation is a major issue for 10–20% of the global population. In a double-blind randomized placebo-controlled clinical trial, we aimed to determine a dose-response effect of galacto-oligosaccharides (GOS) on stool characteristics and fecal microbiota in 132 adults with self-reported constipation according to Rome IV criteria (including less than three bowel movements per week). Subjects (94% females, aged: 18–59 years) received either 11 g or 5.5 g of BiotisTM GOS, or a control product, once daily for three weeks. Validated questionnaires were conducted weekly to study primarily stool frequency and secondary stool consistency. At base- and endline, stool samples were taken to study fecal microbiota. A trend towards an increased stool frequency was observed after the intervention with 11 g of GOS compared to control. While during screening everybody was considered constipated, not all subjects (n = 78) had less than three bowel movements per week at baseline. In total, 11 g of GOS increased stool frequency compared to control in subjects with a low stool frequency at baseline (≤3 bowel movements per week) and in self-reported constipated adults 35 years of age or older. A clear dose-response of GOS was seen on fecal Bifidobacterium, and 11 g of GOS significantly increased Anaerostipes hadrus. In conclusion, GOS seems to be a solution to benefit adults with a low stool frequency and middle-aged adults with self-reported constipation.
Highlights
Constipation is one of the most common digestive problems in Western countries and can be defined as difficult, unsatisfactory, or infrequent defecation [1]
Subjects that had any of the following criteria were excluded from participation: major abdominal surgery interfering with GI function, major comorbidities that may have an impact on the study results, use of medication that may affect the results of the investigational product, use of antibiotics within 90 days before start of the study, use of strict diets, self-reported lactose-intolerance, self-reported cow’s milk protein allergy, diagnosed diabetes, pregnant and lactating women, expected change in lifestyle within 14 days before and during the trial period, history of side effects with the use of prebiotic supplements, use of alcoholic beverages for men >28 units/week and
This study demonstrates a trend towards an increased stool frequency after three weeks of intervention with 11 g of GOS in adults with self-reported constipation, and a significant increase in adults with low stool frequency (≤3 bowel movements per week)
Summary
Constipation is one of the most common digestive problems in Western countries and can be defined as difficult, unsatisfactory, or infrequent defecation [1]. Constipation is a major issue for 10–20% of the global population [2,3,4]. It is more common in women than in men and more frequent in older adults [5]. The current interventions for constipation include lifestyle and dietary modifications as well as pharmacological interventions with stool softeners, osmotic laxatives, stimulant laxatives, and bulking agents [8,9,10]. Dietary modifications include an increased intake of fiber-rich fruits and vegetables together with a sufficient intake of water. Other factors to be considered are physical activity and stress [10,11]
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