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Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire (IBSQUtrition)

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ClinicalTrials.gov Identifier: NCT03824821
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
Netherlands: Ministry of Health, Welfare and Sports
Ingredia S.A.
Nexira
Naturex
Bioiberica
Wecare
Roquette Freres
Darling
Winclove
Information provided by (Responsible Party):
Wageningen University

Study Description
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Brief Summary:

This study is a cross-sectional observational study design that aimed to include 2000 IBS patients. We used several validated questionnaires, to assess IBS characteristics (such as subtype, severity), psychological features (QoL, anxiety and depression) and assess nutritional triggers.

Subjects filled in the questionnaire online, and was spread across the Netherlands.


Condition or disease Intervention/treatment
Irritable Bowel Syndrome Other: No intervention

Study Design
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Study Type : Observational
Actual Enrollment : 2076 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
IBS Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. IBS subtype [ Time Frame: 1 day (once ) ]
    Assessed using the Validated Bristol stool chart

  2. IBS severity [ Time Frame: 1 day (once ) ]
    Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case

  3. Nutrition questionnaire [ Time Frame: 1 day (once ) ]
    We composed a questionnaire containing 44 identified nutritional triggers from literature, and asked subjects if they had (0, no complaints), 1 little complaints, 2 severe complaints, after eating that product.

  4. Birmingham symptom questionnaire [ Time Frame: 1 day (once ) ]
    Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation


Secondary Outcome Measures :
  1. Irritable bowel syndrome Quality of Life questionnaire [ Time Frame: 1 day (once ) ]
    We used the validated IBS-QOL which asked 44 questions about quality of life related to IBS. Score ranged from 0 - 100: 100 indicating a very high quality of life, 0 indicating a very poor quality of life

  2. Hospital Anxiety and Depression Score (HADS) [ Time Frame: 1 day (once ) ]
    We used the validated HADS questionnaire to assess anxiety and depression in IBS patients. This questionnaire gives 2 scores: one for anxiety and depression. Scores range from 0-21, a score above 8 can be referred to as being a case for having anxiety or depression

  3. treatment options currently used [ Time Frame: 1 day (once ) ]
    We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was.

  4. Rome IV criteria [ Time Frame: 1 day (once ) ]
    Validated questions to check whether a subject fits within the profile of IBS


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
There were no strict inclusion and exclusion criteria, since many IBS patients do not have an official diagnosis of IBS. therefore, the ROME IV diagnostic criteria were included in the questionnaire, to assess whether subjects fit within the IBS profile.
Criteria

Inclusion Criteria:

  • IBS-like symptoms

Exclusion Criteria:

  • younger than 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824821


Locations
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Netherlands
Wageningen University & Research
Wageningen, Netherlands, 6700 VB
Sponsors and Collaborators
Wageningen University
Netherlands: Ministry of Health, Welfare and Sports
Ingredia S.A.
Nexira
Naturex
Bioiberica
Wecare
Roquette Freres
Darling
Winclove
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT03824821    
Other Study ID Numbers: 18/06
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wageningen University:
Nutrition
Irritable Bowel Syndrome
Quality of Life
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases