Boosting Biologics in UC
Primary Purpose
Ulcerative Colitis, Inflammatory Bowel Diseases
Status
Recruiting
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
IDOFORM®Travel
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
Subjects may be included as cases in the study if they meet all of the following criteria:
- Diagnosed With ulcerative colitis based on Lennard-Jones criteria
- Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
- Failure to Reach remission upon routine evaluation colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≥ using the Mayo score for ulcerative colitis
- Age 18-75
- Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
Subjects may be included as Control subjects in the sub-study if they meet all of the following criteria:
- Diagnosed With ulcerative colitis based on Lennard-Jones Criteria
- Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
- Remission upon routine colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≤ using the Mayo score for ulcerative colitis
- Age 18-75
- Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
OR if they meet all the following criteria:
- No history of inflammatory bowel disease
- Age 18-75
- Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
Exclusion Criteria:
- Clinical status poor to such extent that treating physician finds refraining from escalation of treatment contraindicated
- Signs of severe ulcerative colitis as defined by the "Montreal classification of severity of ulcerative colitis" = 3: Passage of at least six bloody stools daily, pulse rate of at least 90 beats per minute, temperature of at least 37.5°C, haemoglobin of less than 10.5 g/100 ml, and erythrocyte sedimentation rate (ESR) of at least 30 mm/h.
- Previous use of anti-TNF medication
- History of bowel resection, other inflammatory bowel disease (IBD)-related surgery, or other major intestinal surgery
- Plasma hepatitis C (HCV) positive
- Serum hepatitis B surface antigen (HBsAg) positive
- HIV positive
- Comorbidity of coeliac disease or malnutrition
- Pregnancy
- Concomitant use of non-steroid anti-inflammatory drugs (NSAIDS) or corticosteroids
- Concomitant use of antithrombotic pharmaceutical substances
- Regular (weekly) use of any probiotic substance within 3 months prior to inclusion
- Use of antibiotics within 3 months prior to inclusion
- Deranged liver function (serum albumin < 25 g/L or Child-Pugh ≥10)
- Renal failure (estimated glomerular filtration rate (eGFR) < 30
- Heart failure (NYHA class II-IV)
- Any reason why, in the opinion of the investigator, the patient should not participate
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention with probiotics
Arm Description
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).
Outcomes
Primary Outcome Measures
Adverse events
Unit of Measure: Frequency
Total Mayo Score for Ulcerative Colitis
Alterations in Total Mayo Score at time of control colonoscopy. Minimal value=0 (best outcome), Maximal value = 12 (worst outcome)
Change in Fecal Calprotectin
Change in Fecal Calprotectin from baseline (week 0) to end of intervention (week 8) and after intervention (week 12).
Unit of measure: mg/kg
Secondary Outcome Measures
Alterations in mucosa-adherent microbial composition
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
Exploratory (Unit of Measure: Descriptive)
Alterations in markers of chronic inflammation / immune activation
Explorative (Unit of Measure: Descriptive)
Full Information
NCT ID
NCT04241029
First Posted
January 17, 2020
Last Updated
September 20, 2022
Sponsor
Oslo University Hospital
Collaborators
Helse Sor-Ost
1. Study Identification
Unique Protocol Identification Number
NCT04241029
Brief Title
Boosting Biologics in UC
Official Title
Boosting Biologics in Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Helse Sor-Ost
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention with probiotics
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
IDOFORM®Travel
Intervention Description
Four capsules IDOFORM®Travel orally every 24 hour (12*10^9 cfu/day) for eight weeks.
Primary Outcome Measure Information:
Title
Adverse events
Description
Unit of Measure: Frequency
Time Frame
8 weeks
Title
Total Mayo Score for Ulcerative Colitis
Description
Alterations in Total Mayo Score at time of control colonoscopy. Minimal value=0 (best outcome), Maximal value = 12 (worst outcome)
Time Frame
8 weeks
Title
Change in Fecal Calprotectin
Description
Change in Fecal Calprotectin from baseline (week 0) to end of intervention (week 8) and after intervention (week 12).
Unit of measure: mg/kg
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Alterations in mucosa-adherent microbial composition
Description
Exploratory analyses of microbial composition at baseline (week 0) and at end of intervention (week 8). (Unit of Measure: Descriptive)
Time Frame
8 weeks
Title
Alterations in epithelial gene expression
Description
Exploratory (Unit of Measure: Descriptive)
Time Frame
8 weeks
Title
Alterations in markers of chronic inflammation / immune activation
Description
Explorative (Unit of Measure: Descriptive)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects may be included as cases in the study if they meet all of the following criteria:
Diagnosed With ulcerative colitis based on Lennard-Jones criteria
Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
Failure to Reach remission upon routine evaluation colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≥ using the Mayo score for ulcerative colitis
Age 18-75
Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
Subjects may be included as Control subjects in the sub-study if they meet all of the following criteria:
Diagnosed With ulcerative colitis based on Lennard-Jones Criteria
Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
Remission upon routine colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≤ using the Mayo score for ulcerative colitis
Age 18-75
Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
OR if they meet all the following criteria:
No history of inflammatory bowel disease
Age 18-75
Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
Exclusion Criteria:
Clinical status poor to such extent that treating physician finds refraining from escalation of treatment contraindicated
Signs of severe ulcerative colitis as defined by the "Montreal classification of severity of ulcerative colitis" = 3: Passage of at least six bloody stools daily, pulse rate of at least 90 beats per minute, temperature of at least 37.5°C, haemoglobin of less than 10.5 g/100 ml, and erythrocyte sedimentation rate (ESR) of at least 30 mm/h.
Previous use of anti-TNF medication
History of bowel resection, other inflammatory bowel disease (IBD)-related surgery, or other major intestinal surgery
Plasma hepatitis C (HCV) positive
Serum hepatitis B surface antigen (HBsAg) positive
HIV positive
Comorbidity of coeliac disease or malnutrition
Pregnancy
Concomitant use of non-steroid anti-inflammatory drugs (NSAIDS) or corticosteroids
Concomitant use of antithrombotic pharmaceutical substances
Regular (weekly) use of any probiotic substance within 3 months prior to inclusion
Use of antibiotics within 3 months prior to inclusion
Deranged liver function (serum albumin < 25 g/L or Child-Pugh ≥10)
Renal failure (estimated glomerular filtration rate (eGFR) < 30
Heart failure (NYHA class II-IV)
Any reason why, in the opinion of the investigator, the patient should not participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonas Lundekvam, MD
Phone
+47 45282558
Email
jonasalu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asle Medhus, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Andre Lundekvam, MD
Phone
004723015981
Email
joalun@ous-hf.no
12. IPD Sharing Statement
Learn more about this trial
Boosting Biologics in UC
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