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Boosting Biologics in UC

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ClinicalTrials.gov Identifier: NCT04241029
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Asle W. Medhus, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE January 17, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE February 25, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Boosting Biologics in UC
Official Title  ICMJE Boosting Biologics in Ulcerative Colitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Inflammatory Bowel Diseases
Intervention  ICMJE Dietary Supplement: IDOFORM®Travel
Four capsules IDOFORM®Travel orally every 24 hour (12*10^9 cfu/day) for eight weeks.
Study Arms  ICMJE 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).
Intervention: Dietary Supplement: IDOFORM®Travel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jonas Lundekvam, MD +47 45282558 jonasalu@gmail.com
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241029
Other Study ID Numbers  ICMJE 2016/2269
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asle W. Medhus, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Helse Sor-Ost
Investigators  ICMJE
Principal Investigator: Asle Medhus, MD, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP