Nutrition to Relieve IBS Constipation

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

DIETARY_SUPPLEMENT

Probiotic supplement

Use of a probiotic sachet

DIETARY_SUPPLEMENT

Prebiotic supplement

Prebiotic sachets

DIETARY_SUPPLEMENT

Maltodextrin

Placebo comparator

Sponsors & Collaborators

• Ministery of Economic affairs

  collaborator UNKNOWN

• Nexira

  collaborator INDUSTRY

• Wecare

  collaborator OTHER

• Roquette Freres

  collaborator INDUSTRY

• Ingredion Incorporated

  collaborator INDUSTRY

• Ingredia S.A.

  collaborator INDUSTRY

• Naturex

  collaborator OTHER

• Winclove Probiotics B.V.

  collaborator INDUSTRY

• Bioiberica

  collaborator INDUSTRY

• Darling Ingredients

  collaborator UNKNOWN

• Wageningen University and Research

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-08

Primary Completion

2021-07-15

Completion

2021-07-15

Countries

• Netherlands

Study Locations