The influence of alterations in the intestinal microbiome on the clinical course of inflammatory bowel disease

• Conditions: IBD; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON45843
• 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: 250

Inclusion Criteria

Aged > 18
Confirmed CD or UC or IBD-unspecified 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 bacterial species<br /><br>and phyla.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Blood parameters including CRP, leukocytes and inflammatory cytokines<br /><br>* Fatigue scores measured by FACIT-F and MFI<br /><br>* Anxiety, depression scores measured by PROMIS NIH questionnaires<br /><br>* Relapse (defined as FCP>250 µg/g, elevated CRP levels, and HBI*4 or SCCAI*2)<br /><br>* Quality of life measured by SIBDQ<br /><br>* Dietary habits measured by a series of 24-hour recalls and a food additive<br /><br>questionnaire<br /><br>* Medication adherence measured by MAS-8</p><br>