Nutrition to Relieve IBS Constipation

Study Overview
=================
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.

Official Title
-----------------
Nutrition to Relieve IBS Constipation

Conditions
-----------------
Irritable Bowel Syndrome, Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic supplement
* Dietary Supplement: Prebiotic supplement
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br> | Dietary Supplement: Probiotic supplement<br>* Use of a probiotic sachet<br>|
| Experimental: Prebiotic<br> | Dietary Supplement: Prebiotic supplement<br>* Prebiotic sachets<br>|
| Placebo Comparator: Maltodextrin<br> | Dietary Supplement: Maltodextrin<br>* Placebo comparator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation severity | Will be measured using the validated questionnaire PAC-SYM | during week 1, week 4 and week 8 of the study | 
| Irritable Bowel Syndrome severity | Will be measured using the validated questionnaire IBS-SSS | during week 1, week 4 and week 8 of the study | 
| Constipation related quality of life | will be measured using the validated questionnaire PAC-QOL | during week 1, week 4 and week 8 of the study | 
| Dietary intake | will be measured using a validated food frequency questionnaire | during week 1, week 4 and week 8 of the study | 
| Mental wellbeing | Will be measured using the validated HADS questionnaire | during week 1, week 4 and week 8 of the study | 
| gastro-intestinal complaints | will be measured on a visual analog scale | daily for 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prebiotic, Probiotic