The possible influences of the gastrointestinal microbiome on fatigue and the disease course of inflammatory bowel disease: a prospective follow-up study

• Conditions: Crohn's disease; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON47957
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Aged 18 or older
Confirmed Crohn's disease based on diagnostic criteria using clinical symptoms,
endoscopic, biochemical and or histological results

Exclusion Criteria

-Use of pre-, pro- and/or antibiotics within 8 weeks prior to start of the study
- Presence of active malignancy or dysplasia
- Pregnant and/or breastfeeding women
- Presence of active rotavirus or clostridium infection at start of study
- Patients with a pouch or stoma

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the composition of the patients* intestinal<br /><br>microbiome defined by the proportion and diversity of fecal bacteria species<br /><br>and phyla, and its effect on fatigue measured by different questionnaires. This<br /><br>will be measured every three months over the course of two years to account for<br /><br>changes in the composition of the microbiome over time.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>What is the influence of alterations in the intestinal microbiome composition<br /><br>on the course of disease in patients with Crohn's disease?<br /><br>Anxiety and depression<br /><br>Quality of life<br /><br>Disability<br /><br>Blood parameters</p><br>