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NCT03824821 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

— IBSQUtrition  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03824821
Other study ID # 18/06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 22, 2018
Est. completion date May 31, 2018

Study information
Verified date January 2019
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2076
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- IBS-like symptoms

Exclusion Criteria:

- younger than 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
Netherlands Wageningen University & Research Wageningen

Sponsors (10)
Lead Sponsor Collaborator
Wageningen University Bioiberica, Darling, Ingredia, Naturex, Netherlands: Ministry of Health, Welfare and Sports, Nexira, Roquette Freres, Wecare, Winclove

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary IBS subtype Assessed using the Validated Bristol stool chart 1 day (once )
Primary 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 )
Primary 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 )
Primary Birmingham symptom questionnaire Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation 1 day (once )
Secondary 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 )
Secondary 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 )
Secondary 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 )
Secondary Rome IV criteria Validated questions to check whether a subject fits within the profile of IBS 1 day (once )
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