NCT04241029

Boosting Biologics in UC

Boosting Biologics in Ulcerative Colitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety of the probiotic compound IDOFORM TRAVEL® in patients with ulcerative colitis undergoing anti-TNF treatment with insufficient clinical response. Furthermore, the study aims to explore the composition of the bacteria of the gut as well as the immunological activity in patients with ulcerative colitis undergoing anti-TNF treatment, aiming to identify differences between groups of patients responding and not responding adequately to treatment. The project will explore whether probiotics have beneficial effects as adjuvant therapy in ulcerative colitis patients with insufficient response to anti-TNF treatment.

Detailed description

The use of anti TNF agents has improved the medical treatment of ulcerative colitis (UC). However, one third of patients receiving such treatment will not reach remission. Studies have demonstrated that the gut microbiome influences the cytokine response and in particular the TNF production. In this study we aim to manipulate the gut microbiome in patients with ulcerative colitis not responding to anti-TNF therapy to evaluate potential beneficial effects. 20 UC patients with insufficient response to anti-tumor necrosis factor (anti-TNF) therapy upon routine evaluation colonoscopy 6-12 months after start of treatment will receive intervention with the probiotic formula IDOFORM Travel®, 4 capsules daily for 8 weeks. A colonoscopy will be performed at baseline (week 0) and after intervention (week8). Gut biopsies, fecal samples and serological markers will, in addition to clinical examination and endoscopic results, be used to evaluate the safety and possible beneficial effects of the intervention. In a subsidiary cross-sectional study, 20 UC patients on anti-TNF therapy in remission upon evaluation colonoscopy will serve as controls. 20 individuals with no history of inflammatory bowel disease will be recruited as healthy controls.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	IDOFORM®Travel	Four capsules IDOFORM®Travel orally every 24 hour (12\*10\^9 cfu/day) for eight weeks.

Timeline

• Start date: 2020-02-25
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2020-01-27
• Last updated: 2024-05-06

Locations

1 site across 1 country: Norway