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Completed

NCT Number: NCT03824821

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wageningen University & Research

Wageningen, 6700 VB, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IBS-like symptoms

Exclusion criteria

  • younger than 18 years

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. IBS subtype

    Time frame: 1 day (once )

    Assessed using the Validated Bristol stool chart

  2. IBS severity

    Time frame: 1 day (once )

    Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case

  3. Nutrition questionnaire

    Time frame: 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.

  4. Birmingham symptom questionnaire

    Time frame: 1 day (once )

    Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation

Secondary outcomes

  1. Irritable bowel syndrome Quality of Life questionnaire

    Time frame: 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

  2. Hospital Anxiety and Depression Score (HADS)

    Time frame: 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

  3. treatment options currently used

    Time frame: 1 day (once )

    We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was.

  4. Rome IV criteria

    Time frame: 1 day (once )

    Validated questions to check whether a subject fits within the profile of IBS

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Bioiberica
  • Darling
  • Ingredia S.A.
  • Naturex
  • Netherlands: Ministry of Health, Welfare and Sports
  • Nexira
  • Roquette Freres
  • Wecare
  • Winclove Probiotics B.V.

Registry information

Acronym: IBSQUtrition

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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