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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

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Diseases Dietary Supplement: IDOFORM®Travel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 8 weeks ]
    Unit of Measure: Frequency

  2. 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)

  3. 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



Secondary Outcome Measures :
  1. 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)

  2. Alterations in epithelial gene expression [ Time Frame: 8 weeks ]
    Exploratory (Unit of Measure: Descriptive)

  3. Alterations in markers of chronic inflammation / immune activation [ Time Frame: 8 weeks ]
    Explorative (Unit of Measure: Descriptive)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jonas Lundekvam, MD +47 45282558 jonasalu@gmail.com

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Jonas Andre Lundekvam, MD    004723015981    joalun@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Helse Sor-Ost
Investigators
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Principal Investigator: Asle Medhus, MD, PhD Oslo University Hospital
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Responsible Party: Asle W. Medhus, Head of dep. of Gastroenterology, OUH. MD, PhD., Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04241029    
Other Study ID Numbers: 2016/2269
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes