Nutrition to Relieve IBS Symptoms by Targeting the Microbiota (NUTRIMI)

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Dietary fiber supplement; Dietary supplement: Caseine protein hydrolisate; Dietary supplement: Maltrodextrine

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IBS patients that meet the Rome IV criteria. This will be evaluated by the medical supervisor;
• Male and female adults, aged 18-65 years;
• Having a Body Mass Index (BMI) between 18.5 and 30 kg/m2;
• Willing to keep a stable dietary pattern throughout the study;
• Having a smartphone to fill out the daily questionnaires.

Exclusion Criteria:

• Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis;
• Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy;
• Having a food allergy to milk protein or pulse protein;
• Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease;
• When applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and wellbeing;
• Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study;
• Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements. Some supplements are allowed, but intake should be kept stable during the whole study period (Supplements will be judged by the medical supervisor MD Ben Witteman);
• Currently following a FODMAP-restricted diet;
• Use of medication that can interfere with the study outcomes, including anxiolytics, proton pump inhibitors, laxatives (Over-the-counter laxatives are allowed, but intake should be either stopped before the start of the study or kept stable during the complete study period), and codeine, as judged by the medical supervisor MD Ben Witteman;
• Participation in another clinical trial at the same time;
• Student or employee working at Food, Health and Consumer Research from Wageningen Food and Biobased Research;
• Alcohol intake ≥ 2 (women) or ≥ 4 (men) glasses of alcoholic beverages per day;
• Abuse of illicit drugs;
• Being incapacitated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary fiber 1	Dietary supplement: Dietary fiber supplement; Dietary fiber
Experimental: Dietary fiber 2	Dietary supplement: Dietary fiber supplement; Dietary fiber
Experimental: dietary fiber 3	Dietary supplement: Dietary fiber supplement; Dietary fiber
Experimental: caseine protein hydrolisate	Dietary supplement: Caseine protein hydrolisate; Dietary supplement
Placebo Comparator: Maltodextrine	Dietary supplement: Maltrodextrine; Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abundance of feceal Bifidobacterium	Measured in fecal samples using 16S rRNA gene-based approaches	Change after the intervention of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fecal microbiota composition	Measured in fecal samples using 16S rRNA gene-based approaches	Change after the intervention of 4 weeks
fecal microbiota metabolite levels	Measured in the fecal samples using HPLC	Change after the intervention of 4 weeks
Stool frequency	Questions regarding how often participants defecate	daily during 4 weeks
Stool consistency	Using the validated Bristol stool chart	daily during 4 weeks
gastro-intestinal complaints	Measured with a visual analog scale	daily during 4 weeks
Irritable Bowel Syndrome severity	measured using the validated IBS-SSS questionnaire	4 weeks
Irritable Bowel Syndrome related quality of life	measured using the validated IBS-QoL questionnaire	4 weeks
mental wellbeing	measuring using the validated hospital anxiety and despression score (HADS) questionnaire	4 weeks
dietary intake	Measured via a validated food frequency questionnaire (FFQ)	4 weeks

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Nexira; Roquette Freres; Bioiberica; Ingredion Incorporated; Winclove Probiotics B.V.; Naturex; Ministery of Economic affairs; Wecare; Ingredia S.A.; Darling Ingredients

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: gut Microbiota
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: NL75824.041.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No