Boosting Biologics in UC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04241029|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 4, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Inflammatory Bowel Diseases||Dietary Supplement: IDOFORM®Travel||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Boosting Biologics in Ulcerative Colitis|
|Actual Study Start Date :||February 25, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Intervention with probiotics
Intervention with the probiotic compound IDOFORM®Travel. The patient will receive four capsules orally every 24 hour (12*10^9 cfu/day) for eight weeks as adjuvant therapy to his/her anti-TNF treatment. The intervention arm will at the end of intervention serve as their own controls compared to baseline data (before intervention).
Dietary Supplement: IDOFORM®Travel
Four capsules IDOFORM®Travel orally every 24 hour (12*10^9 cfu/day) for eight weeks.
- Adverse events [ Time Frame: 8 weeks ]Unit of Measure: Frequency
- Total Mayo Score for Ulcerative Colitis [ Time Frame: 8 weeks ]Alterations in Total Mayo Score at time of control colonoscopy. Minimal value=0 (best outcome), Maximal value = 12 (worst outcome)
- Change in Fecal Calprotectin [ Time Frame: 12 weeks ]
Change in Fecal Calprotectin from baseline (week 0) to end of intervention (week 8) and after intervention (week 12).
Unit of measure: mg/kg
- Alterations in mucosa-adherent microbial composition [ Time Frame: 8 weeks ]Exploratory analyses of microbial composition at baseline (week 0) and at end of intervention (week 8). (Unit of Measure: Descriptive)
- Alterations in epithelial gene expression [ Time Frame: 8 weeks ]Exploratory (Unit of Measure: Descriptive)
- Alterations in markers of chronic inflammation / immune activation [ Time Frame: 8 weeks ]Explorative (Unit of Measure: Descriptive)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241029
|Contact: Jonas Lundekvam, MD||+47 email@example.com|
|Oslo University Hospital||Recruiting|
|Contact: Jonas Andre Lundekvam, MD 004723015981 firstname.lastname@example.org|
|Principal Investigator:||Asle Medhus, MD, PhD||Oslo University Hospital|