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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03824821
Acronym
IBSQUtrition
Enrollment
2076
Registered
2019-01-31
Start date
2018-01-22
Completion date
2018-05-31
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Nutrition, Irritable Bowel Syndrome, Quality of Life

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Netherlands: Ministry of Health, Welfare and Sports
CollaboratorOTHER_GOV
Ingredia S.A.
CollaboratorINDUSTRY
Nexira
CollaboratorINDUSTRY
Naturex
CollaboratorOTHER
Bioiberica
CollaboratorINDUSTRY
Wecare
CollaboratorOTHER
Roquette Freres
CollaboratorINDUSTRY
Darling
CollaboratorUNKNOWN
Winclove Probiotics B.V.
CollaboratorINDUSTRY
Wageningen University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* IBS-like symptoms

Exclusion criteria

* younger than 18 years

Design outcomes

Primary

MeasureTime frameDescription
IBS subtype1 day (once )Assessed using the Validated Bristol stool chart
IBS severity1 day (once )Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case
Nutrition questionnaire1 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 questionnaire1 day (once )Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation

Secondary

MeasureTime frameDescription
Irritable bowel syndrome Quality of Life questionnaire1 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
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
treatment options currently used1 day (once )We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was.
Rome IV criteria1 day (once )Validated questions to check whether a subject fits within the profile of IBS

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026