DISCOvERIE: Development, dIagnosis, and prevention of gender-related Somatic and mental COmorbitiEs in iRritable bowel syndrome In Europe

Completed

Conditions: Irritable bowel syndrome
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Registration Number: NL-OMON55114

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 102

Inclusion Criteria

- Diagnosis of IBS according to Rome IV criteria
- Aged 18 years or older
- Ability to understand written Dutch and speak the Dutch language

Exclusion Criteria

- Any organic explanation for the abdominal complaints.
- A history of abdominal surgery, except for uncomplicated appendectomy,
laparoscopic cholecystectomy, and hysterectomy.
- Participation in another clinical study interfering with study activities or
study objectives of this study, 1 month prior to the screening visit and
throughout the study.
- Other severe disease(s) such as malignancy, severe heart disease, kidney
disease or neurological disease, interfering with study evaluations.
- Severe psychiatric disease, other than the comorbid conditions explicitly
studied, with necessary additional psychopharmacotherapy or psychiatric
intervention involving day-care/ inpatient treatment at start of study or
during the study, especially a diagnosis of bipolar disorder, schizophrenia,
autism spectrum disorder, schizoaffective disorder or organic psychiatric
disorder (current OR lifetime).
- Previous history of drug or alcohol abuse 6 months prior to screening.
- Consumption of antibiotics 3 months prior to the baseline visit.
- Pregnant or lactating at the baseline visit.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study outcomes are divided into clinical characteristics (symptom scores for GI<br /><br>symptoms, other somatic symptoms, fatigue, psychological symptoms, nutrition,<br /><br>physical activity, and sleep pattern) and biological parameters (measurements<br /><br>from blood samples, fecal samples, colon biopsies, and a multi-sugar<br /><br>permeability test, and two stress assessments targeted at different<br /><br>pathophysiological mechanisms).<br /><br>Primary study parameters are symptom scores from questionnaires:<br /><br>- GI symptoms: IBS-SSS.<br /><br>- Somatic symptoms other than GI symptoms: PHQ-15.<br /><br>- Symptoms and severity of fibromyalgia: FIQ.<br /><br>- Psychological symptoms: GAD-7, PHQ-9.<br /><br>- Presence and severity of fatigue: MFI.<br /><br>- Nutritional pattern: FFQ.</p><br>

Secondary Outcome Measures