Effect of dietary therapy with a probiotic mixture (Ecologic BARRIER) on the gut microbiome and fatigue symptoms in patients with quiescent inflammatory bowel disease - A clinical trial

• Conditions: Crohn's Disease; Inflammatory bowel disease; Ulcerative colitis; 10017969

• Registration Number: NL-OMON46575
• 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: 60

Inclusion Criteria

* Age 18-75 years
* Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria
* Quiescent disease defined as HBI * 4 for CD and SCCAI * 2 for UC
* Persistent ongoing fatigue symptoms, defined as FACIT-F < 43
* Normal fecal calprotectin (< 250ug/g) and C-reactive protein (< 8mg/L) within 12 months of screening
* Endoscopic or radiologic remission within 12 months of screening

Exclusion Criteria

* Patients with clinical or endoscopically active inflammatory bowel disease
* Significant non-IBD comorbidity contributing to the fatigue (such as active cancer).
* Untreated severe depression or anxiety
* Known sleep disorders without adequate treatment,
* Concurrent use of narcotics or long-term oral antibiotic therapy
* Severe vitamin D deficiency (< 10 ng/mL)
* J-pouch or a stoma
* Ongoing use of other non-study probiotics
* Women who are pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified