Nutrition to Relieve IBS Constipation

NCT04798417 | Completed

• 1 other identifier: NL76449.041.21
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Constipation

Keywords

Prebiotic; Probiotic

Outcome Measures

Primary Outcomes (3)

• Stool frequency

  Number of stools per day will be questioned

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

• Stool consistency

  Will be assessed using the Bristol stool Chart

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

• stool volume

  Participants will weigh every stool that they have during 5 days

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

Secondary Outcomes (6)

• Constipation severity

  during week 1, week 4 and week 8 of the study

• Irritable Bowel Syndrome severity

  during week 1, week 4 and week 8 of the study

• Constipation related quality of life

  during week 1, week 4 and week 8 of the study

• Dietary intake

  during week 1, week 4 and week 8 of the study

• Mental wellbeing

  during week 1, week 4 and week 8 of the study

Study Arms (3)

Probiotic

EXPERIMENTAL

Dietary Supplement: Probiotic supplement

Prebiotic

EXPERIMENTAL

Dietary Supplement: Prebiotic supplement

Maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin

Interventions

Probiotic supplement DIETARY_SUPPLEMENT

Use of a probiotic sachet

Probiotic

Prebiotic supplement DIETARY_SUPPLEMENT

Prebiotic sachets

Prebiotic

Maltodextrin DIETARY_SUPPLEMENT

Placebo comparator

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Related Publications (1)

• JanssenDuijghuijsen L, van den Belt M, Rijnaarts I, Vos P, Guillemet D, Witteman B, de Wit N. Acacia fiber or probiotic supplements to relieve gastrointestinal complaints in patients with constipation-predominant IBS: a 4-week randomized double-blinded placebo-controlled intervention trial. Eur J Nutr. 2024 Aug;63(5):1983-1994. doi: 10.1007/s00394-024-03398-8. Epub 2024 Apr 23.

  PMID: 38653808 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 15, 2021
• Study Start: March 8, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)