Irritable Bowel SyndromeIBSQUtritionNCT03824821
Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire
An observational study of Irritable Bowel Syndrome, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 2,076 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2018to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: There were no strict inclusion and exclusion criteria, since many IBS patients do not have an official diagnosis of IBS. therefore, the ROME IV diagnostic criteria were included in the questionnaire, to assess whether subjects fit within the IBS profile.
Who may be able to join
- IBS-like symptoms
Who cannot join
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- No intervention
- Keywords
- Nutrition, Irritable Bowel Syndrome, Quality of Life
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| IBS | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS subtype
Assessed using the Validated Bristol stool chart
Measured: 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
Measured: 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.
Measured: 1 day (once )
Birmingham symptom questionnaire
Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation
Measured: 1 day (once )
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 1 day (once )
Rome IV criteria
Validated questions to check whether a subject fits within the profile of IBS
Measured: 1 day (once )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start22 Jan 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, Ingredia S.A., Nexira, Naturex, Bioiberica, Wecare, Roquette Freres, Darling, Winclove Probiotics B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824821
- Sponsor's protocol ID
- 18/06
- Acronym
- IBSQUtrition
- Status last verified
- Jan 2019
- First submitted
- 29 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire
- ClinicalTrials.gov ID
- NCT03824821
- Acronym / sponsor ID
- IBSQUtrition / 18/06
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Nutrition, Irritable Bowel Syndrome, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,076 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, Ingredia S.A., Nexira, Naturex, Bioiberica, Wecare, Roquette Freres, Darling, Winclove Probiotics B.V.
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- There were no strict inclusion and exclusion criteria, since many IBS patients do not have an official diagnosis of IBS. therefore, the ROME IV diagnostic criteria were included in the questionnaire, to assess whether subjects fit within the IBS profile.
Key inclusion criteria (1 listed)
- IBS-like symptoms
Key exclusion criteria (1 listed)
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | IBS |
Primary outcome
IBS subtype
Time frame: 1 day (once )
Assessed using the Validated Bristol stool chart
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
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.
Birmingham symptom questionnaire
Time frame: 1 day (once )
Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation
4 secondary outcomes
Irritable bowel syndrome Quality of Life questionnaire
Time frame: 1 day (once )
Hospital Anxiety and Depression Score (HADS)
Time frame: 1 day (once )
treatment options currently used
Time frame: 1 day (once )
Rome IV criteria
Time frame: 1 day (once )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS subtype (time frame: 1 day (once )). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.