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Nutrition to Relieve IBS Constipation (NUTRIC)

Primary Purpose

Irritable Bowel Syndrome, Constipation

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Probiotic supplement

Prebiotic supplement

Maltodextrin

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Prebiotic, Probiotic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

IBS patients that meet the Rome IV criteria + additional criteria specific for the constipation-predominant subtype, based on the most frequent self-reported stool types using the Bristol stool chart (BSC). These criteria will be assessed via the inclusion questionnaire and will be evaluated by the medical supervisor.
Male and female adults, aged 18-70 years.
Have a Body Mass Index (BMI) between 18.5 and 30 kg/m2 (self-reported).
Willing to keep a stable dietary pattern throughout the study.
Having a smartphone to fill out the daily questionnaires

Exclusion Criteria:

Having a disease that may interfere with the outcomes of this study, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism.
History of intestinal surgery (excluding appendectomy or cholecystectomy) or endometriosis.
Use of medication that can interfere with the study outcomes, including antidepressants (allowed when it is not subscribed for mental depression), codeine, and antibiotics, as judged by the medical supervisor MD Ben Witteman.
Use of prescribed 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.
Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements dedicated to bowel function improvements. 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).
If applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool pattern and wellbeing.
Participation in another clinical trial at the same time.
Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition & Health, Wageningen University.
Alcohol intake ≥ 2 (women) or ≥ 4 (men) glasses of alcoholic beverages per day.
Abuse of illicit drugs, soft drugs, and nitrous oxide.
Smoking.

Sites / Locations

Stichting Wageningen Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Prebiotic

Maltodextrin

Arm Description

Outcomes

Primary Outcome Measures

Stool frequency

Number of stools per day will be questioned

Stool consistency

Will be assessed using the Bristol stool Chart

stool volume

Participants will weigh every stool that they have during 5 days

Secondary Outcome Measures

Constipation severity

Will be measured using the validated questionnaire PAC-SYM

Irritable Bowel Syndrome severity

Will be measured using the validated questionnaire IBS-SSS

Constipation related quality of life

will be measured using the validated questionnaire PAC-QOL

Dietary intake

will be measured using a validated food frequency questionnaire

Mental wellbeing

Will be measured using the validated HADS questionnaire

gastro-intestinal complaints

will be measured on a visual analog scale

Full Information

NCT ID

NCT04798417

First Posted

March 4, 2021

Last Updated

July 29, 2021

Sponsor

Wageningen University and Research

Collaborators

Ministery of Economic affairs, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Naturex, Winclove Probiotics B.V., Bioiberica, Darling Ingredients

1. Study Identification

Unique Protocol Identification Number

NCT04798417

Brief Title

Nutrition to Relieve IBS Constipation

Acronym

NUTRIC

Official Title

Nutrition to Relieve IBS Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

July 15, 2021 (Actual)

Study Completion Date

July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wageningen University and Research

Collaborators

Ministery of Economic affairs, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Naturex, Winclove Probiotics B.V., Bioiberica, Darling Ingredients

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Constipation

Keywords

Prebiotic, Probiotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Title

Prebiotic

Arm Type

Experimental

Arm Title

Maltodextrin

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic supplement

Intervention Description

Use of a probiotic sachet

Intervention Type

Dietary Supplement

Intervention Name(s)

Prebiotic supplement

Intervention Description

Prebiotic sachets

Intervention Type

Dietary Supplement

Intervention Name(s)

Maltodextrin

Intervention Description

Placebo comparator

Primary Outcome Measure Information:

Title

Stool frequency

Description

Number of stools per day will be questioned

Time Frame

Change after the intervention, measured at week 1, week 4 and week 8

Title

Stool consistency

Description

Will be assessed using the Bristol stool Chart

Time Frame

Change after the intervention, measured at week 1, week 4 and week 8

Title

stool volume

Description

Participants will weigh every stool that they have during 5 days

Time Frame

Change after the intervention, measured at week 4 and week 8

Secondary Outcome Measure Information:

Title

Constipation severity

Description

Will be measured using the validated questionnaire PAC-SYM

Time Frame