Nutrition to Relieve IBS Symptoms by Targeting the Microbiota

Summary

Rationale: Irritable Bowel Syndrome (IBS) is functional gastrointestinal disorder 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 the microbiota of IBS patients.

Objective: The primary objective is to determine the bifidogenic effects of a 4-week intervention with one of four dietary supplements (Chondroitin sulfate, NOVELOSE® 3490, and Pea Fiber, and Lactium®) in IBS patients. The secondary objective is to determine the effects of the same intervention on fecal microbiota composition and SCFA concentration, IBS-related complaints, Quality of Life, and stool frequency and consistency in IBS patients.

Study design: a double-blind, randomized, placebo-controlled trial with five parallel arms. Study population: 70 adult (18-65 yrs) IBS patients Intervention: 4-week intervention period with five parallel arms: 1) Chondroitin sulfate, 2) NOVELOSE® 3490, 3) Pea Fiber, 4) Lactium®, and 5) Placebo supplement (Maltodextrin control), during which the study participants consume the respective supplement twice per day.

Main study parameters/endpoints: The main study parameter is the (relative) abundance of fecal Bifidobacterium. The secondary study parameters are fecal microbiota composition and Short-Chain Fatty Acids (SCFAs) concentration, stool frequency and consistency, IBS-related complaints, and Quality of Life (QoL).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants have to invest about 7.4 hours of their time in this study mainly to complete several questionnaires (short daily questionnaire, longer questionnaires at two occasions), which is conveniently all possible from home. On two occasions they have to collect stool (transported via courier to the research facility). They have to comply to consume a commercially available supplement twice daily for four weeks. There are limited risks for the study participants.

Conditions

• Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Dietary fiber supplement

Dietary fiber

DIETARY_SUPPLEMENT

Caseine protein hydrolisate

Dietary supplement

DIETARY_SUPPLEMENT

Maltrodextrine

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

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-11

Primary Completion

2021-07-16

Completion

2021-07-16

Countries

• Netherlands

Study Locations