Abstract

The addition of fiber is one of the most important dietary means to relieve constipation through lifestyle modification. Polydextrose (PDX) has been reported in several studies to increase fecal bulk, soften stools, and increase the number of defecations. However, there are few studies on the effect of PDX on colonic transit time (CTT). Therefore, the aim of this study was to demonstrate the effect of PDX on CTT and other aspects of gastrointestinal function during two weeks (Day 1 to Day 14), preceded by a 2-week run-in period (Day -14 to Day -1). A total of 192 adults who were diagnosed with functional constipation per Rome III criteria were recruited for the study. Participants were randomized equally into 4 groups (12 g, 8 g, or 4 g of PDX or placebo per day). The primary endpoint was CTT, assessed using radio-opaque markers and abdominal X-rays on Day 0, the baseline; and Day 15, the end of the intervention. Secondary outcomes that were measured using inventories were the patient assessment of constipation symptoms and quality of life, bowel function index, relief of constipation, bowel movement frequency (BMF), stool consistency, degree of straining, and proportion of bowel movements. Ancillary parameters and harms were also evaluated. The recruited population was not sufficiently constipated (e.g., baseline values for CTT and BMF of 42 h and 8.7 BMF/week, respectively). Despite this limitation, our results demonstrated an increased number of bowel movements when supplemented with PDX at a dosage of 12 g per day for 2 weeks. This dosage also consistently improved the secondary outcomes that were measured using inventories at Day 15, compared with the baseline. No serious or significant adverse events were reported during the study.

Highlights

  • Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12% to 19% [1,2]

  • The patient assessment of constipation symptoms (PAC-SYM) rectal symptom was the only subscale that showed between group differences

  • On Day 15, the 4 g PDX per day participants reported a significant 65% increase (p = 0.034) in their average PAC-SYM rectal symptom subscale compared with the placebo group (Dunnett-adjusted p = 0.027)

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Summary

Introduction

Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12% to 19% [1,2]. The prevalence of constipation is likely to increase with the aging of the population in Western countries [3] and will otherwise be more prevalent with increased adoption of a Western lifestyle. Chronic constipation is diagnosed almost solely based on patient-reported symptoms, which generally include unsatisfactory defecation due to infrequent stools, difficult stool passage, or both [7]. The cause of chronic constipation is multifactorial, with physiological changes, psychological factors, and lifestyle influences identified as possible contributing factors [7]. Evidence-based approaches to managing constipation include fiber, stimulant laxatives, polyethylene glycol, selective serotonin reuptake inhibitors, lubiprostone, and guanylate cyclase agonists

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