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

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: No intervention

• Registration Number: NCT03824821
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2076

Inclusion Criteria

• IBS-like symptoms

Exclusion Criteria

• younger than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBS	No intervention	-

Primary Outcome Measures

Name	Time	Method
IBS subtype	1 day (once )	Assessed using the Validated Bristol stool chart
IBS severity	1 day (once )	Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case
Nutrition questionnaire	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.
Birmingham symptom questionnaire	1 day (once )	Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wageningen University & Research; 🇳🇱 Wageningen, Netherlands