Microbiota Profiling in IBS
Condition: Irritable Bowel Syndrome; Microbial Colonization; Dietary Habits
MeSH terms: Communicable Diseases; Infections; Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      This study investigates differences in microbiota profiles and metabolite levels between mild
      and severe IBS patients, compared to matched healthy controls. Two fecal samples, with one
      month in between, will be analyzed. Secondary parameters such as dietary intake, quality of
      life and stool pattern will be assessed.
    

Detailed description: 
      Rationale: Irritable Bowel Syndrome (IBS) is a gastro-intestinal disorder that strongly
      affects Quality of Life and impairs daily functioning. However, the aetiology and
      pathophysiology has been poorly understood. Studies suggest that intestinal microbiota in IBS
      is altered, however a general consensus remains elusive. This may be due to the large
      individual variation in microbiota and IBS symptoms, and the cross-sectional designs.
      Moreover, other factors like diet, wellbeing and metabolite profiles are often not taken into
      account. New evidence is suggesting that IBS severity may be an important factor in
      microbiota composition.

      Objective: To determine faecal microbiota composition and metabolite production (such as
      acetate, propionate and butyrate), and investigate differences between healthy controls and
      mild or severe patients IBS. Moreover, to investigate whether (clinical) parameters such as
      symptom severity fluctuated, and if these fluctuations are associated with an alteration in
      faecal microbiota composition and metabolite production, one month after baseline, compared
      to healthy controls.

      Study design: This study is a repeated cross-sectional study, with two data collection points
      (baseline, and after one month).

      Study population: For this study, 100 IBS patients and 30 healthy controls will be recruited.
      After the first data collection point (T1), the 30 most mild and 30 most severe IBS patients
      will be included for data collection at T2 (after one month). All participants will be aged
      between 18 and 65 years.

      Intervention (if applicable): Not applicable. Main study parameters/endpoints: primary
      endpoint of this study is microbiota composition and metabolite profiles, and the difference
      between groups and possible change after one month. These are assessed two faecal samples,
      which are analysed by 16S rRNA gene-based microbiota profiling. Secondary parameters are
      dietary intake, Quality of Life, depression and anxiety scores, and stool consistency and
      frequency, which are assessed by validated questionnaires.
    

Intervention name(s): NA observational study
Intervention type(s): Other
Intervention description(s): observational study
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 IBS patients, and 30 healthy matched controls. After baseline measurements, the 30 most
        mild IBS and 30 most severe IBS will be follow-up one month later. n=40 IBS drops out after
        baseline. Healthy controls will be matched with mild IBS patients, based on age, gender and
        BMI.
      
Biospecimen description: 
      Subjects will hand in fecal samples for microbiota composition analysis, which will be done
      using 16r RNA technique.