NCT04798417

Nutrition to Relieve IBS Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heterogeneity of the patients and the complicated pathology in which not all mechanisms are understood. Based on results of in vitro screening within the IBSQUtrition project, we selected promising dietary supplements for validation of their potential beneficial effects on stool pattern in IBS-Constipation (IBS-C) patients. Objective: The primary objective is to determine the effects of a 4-week intervention with either a prebiotic supplement or a probiotic supplement on stool pattern (including stool frequency, consistency, and volume) in IBS-C patients. The secondary objective is to determine the effects if this intervention on GI complaints and quality of life in IBS-C patients. Study design: A double-blind, randomized, placebo-controlled trial will be conducted with three parallel intervention arms Study population: 180 adult (18-70 yrs) IBS patients with a constipation-predominant subtype Intervention: A 4 week run-in period will be followed by a 4-week intervention period with three parallel arms: 1) prebiotic supplement, 2) probiotic supplement, and 3) Placebo supplement, during which the study participants consume the respective supplement twice per day. Main study parameters/endpoints: The primary study parameter is stool pattern: stool frequency, stool consistency; and stool volume. The secondary study parameters are gastrointestinal complaints, Quality of Life, and HADS. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants have to invest about 14.5 hours of their time in this study mainly to complete several questionnaires (short daily questionnaire, longer questionnaires at three occasions), which is conveniently all possible from home. They have to comply to consume a supplement twice daily for four weeks. At two time points they have to collect their stool for five consecutive days. There are limited risks for the study participants.

Conditions

• Irritable Bowel Syndrome
• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic supplement	Use of a probiotic sachet
DIETARY_SUPPLEMENT	Prebiotic supplement	Prebiotic sachets
DIETARY_SUPPLEMENT	Maltodextrin	Placebo comparator

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2021-03-15
• Last updated: 2021-07-30

Locations

1 site across 1 country: Netherlands