Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire
IBSQUtrition
1 other identifier
observational
2,076
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedFirst Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedJanuary 31, 2019
January 1, 2019
4 months
January 29, 2019
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
IBS subtype
Assessed using the Validated Bristol stool chart
1 day (once )
IBS severity
Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case
1 day (once )
Nutrition questionnaire
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.
1 day (once )
Birmingham symptom questionnaire
Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation
1 day (once )
Secondary Outcomes (4)
Irritable bowel syndrome Quality of Life questionnaire
1 day (once )
Hospital Anxiety and Depression Score (HADS)
1 day (once )
treatment options currently used
1 day (once )
Rome IV criteria
1 day (once )
Study Arms (1)
IBS
Interventions
Eligibility Criteria
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.
You may qualify if:
- IBS-like symptoms
You may not qualify if:
- younger than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Netherlands: Ministry of Health, Welfare and Sportscollaborator
- Ingredia S.A.collaborator
- Nexiracollaborator
- Naturexcollaborator
- Bioibericacollaborator
- Wecarecollaborator
- Roquette Frerescollaborator
- Darlingcollaborator
- Winclove Probiotics B.V.collaborator
Study Sites (1)
Wageningen University & Research
Wageningen, 6700 VB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2019
First Posted
January 31, 2019
Study Start
January 22, 2018
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
January 31, 2019
Record last verified: 2019-01