Boosting Biologics in UC

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Oslo University Hospital
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Updated on 16 February 2024
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antibiotic
remission
adalimumab
antibiotics
glomerular filtration rate
heart failure
colitis
immunomodulators
endoscopy
infliximab
ulcerative colitis
adjuvant therapy
ulceration
inflammatory bowel disease
enteropathy
intestinal diseases
intestinal disease

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.

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.

Details
Condition Gastroenteritis, Gastroenteritis, Intestinal Diseases, Ulcerative Colitis, Ulcerative Colitis, Inflammatory bowel disease, Inflammatory bowel disease
Age 18years - 75years
Treatment IDOFORM®Travel
Clinical Study IdentifierNCT04241029
SponsorOslo University Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 37.5C, 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
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antibiotic
remission
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antibiotics
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colitis
immunomodulators
endoscopy
infliximab
ulcerative colitis
adjuvant therapy
ulceration
inflammatory bowel disease
enteropathy
intestinal diseases
intestinal disease

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