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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47957

Enrollment

Registered

2019-11-08

Start date

2019-07-01

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

Crohn's disease Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 bacteria species and phyla, and its effect on fatigue measured by different questionnaires. This will be measured every three months over the course of two years to account for changes in the composition of the microbiome over time.	—

Secondary

Measure	Time frame
What is the influence of alterations in the intestinal microbiome composition on the course of disease in patients with Crohn's disease? Anxiety and depression Quality of life Disability Blood parameters	—

Countries

Netherlands

Outcome results