Irritable bowel syndrome
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study outcomes are divided into clinical characteristics (symptom scores for GI symptoms, other somatic symptoms, fatigue, psychological symptoms, nutrition, physical activity, and sleep pattern) and biological parameters (measurements from blood samples, fecal samples, colon biopsies, and a multi-sugar permeability test, and two stress assessments targeted at different pathophysiological mechanisms). Primary study parameters are symptom scores from questionnaires: - GI symptoms: IBS-SSS. - Somatic symptoms other than GI symptoms: PHQ-15. - Symptoms and severity of fibromyalgia: FIQ. - Psychological symptoms: GAD-7, PHQ-9. - Presence and severity of fatigue: MFI. - Nutritional pattern: FFQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom scores according to momentary assessment using ESM: - GI symptoms - Psychological symptoms Environmental, social, and behavioral features according to momentary assessment using ESM. Lifestyle factors registered by the humanITcare platform: physical activity, heart rate, sleep pattern. Previous traumatic exposure: BTQ. Parameters from biomaterials: - Paracellular in vivo passage of large molecules (i.e. endotoxins, bacterial products): blood samples. - GI permeability studies by multiple sugar test. - Gut microbiota, including bacterial cell counting, metabolomic, transcriptomic and metagenomic analyses, cultivation of micro-organisms: fecal samplen, colon biopsies - Dry weight percentage as an objective measure of stool consistency: fecal samples. - Calprotectin as a measure of (low grade) inflammation: fecal samples. - Whole genome SNP detection as a measure of genetic variants for phenotype association studies: blood samples. - Molecular, cellular, and ultrastructural characterization of the intestinal mucosa, with a specific focus on intestinal barrier function, immune mucosal cell populations and enteric nerve fibers involved in neuro-plastic changes, eosinophil and mast cell degranulation, cell-to-cell interaction, including association between immunocytes, the epithelium and nerve fibers, and molecular transcriptome/proteome profiling: colonic biopsies. - Resting state functional connectivity, regional cerebral blood flow with blood oxygen-dependent level (BOLD) and arterial spin labeling (ASL): fMRI scan during MIST. - Neural responses to psychosocial stress: fMRI scan during MIST. - Subjective and cortisol responses to stress: during MAST. | — |
Countries
Netherlands
Outcome results
None listed