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

The influence of alterations in the intestinal microbiome on the clinical course of inflammatory bowel disease - Intestinal microbiome and disease activity in Inflammatory Bowel Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45843

Enrollment

250

Registered

2018-09-28

Start date

2019-04-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main study parameter is the composition of the patients* intestinal microbiome defined by the proportion and diversity of fecal bacterial species and phyla.	—

Secondary

Measure	Time frame
* Blood parameters including CRP, leukocytes and inflammatory cytokines * Fatigue scores measured by FACIT-F and MFI * Anxiety, depression scores measured by PROMIS NIH questionnaires * Relapse (defined as FCP>250 µg/g, elevated CRP levels, and HBI4 or SCCAI2) * Quality of life measured by SIBDQ * Dietary habits measured by a series of 24-hour recalls and a food additive questionnaire * Medication adherence measured by MAS-8	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results