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

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

Official Title
-----------------
Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS-like symptoms Exclusion Criteria: younger than 18 years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBS<br> | Other: No intervention<br>* No intervention<br>|

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable bowel syndrome Quality of Life questionnaire | 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 | 1 day (once ) | 
| Hospital Anxiety and Depression Score (HADS) | 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 | 1 day (once ) | 
| treatment options currently used | We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was. | 1 day (once ) | 
| Rome IV criteria | Validated questions to check whether a subject fits within the profile of IBS | 1 day (once ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Irritable Bowel Syndrome, Quality of Life