Boosting Biologics in UC

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04241029
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Oslo University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Asle Medhus, MD, PhD
Principal Investigator Affiliation Oslo University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis, Inflammatory Bowel Diseases
Additional Details

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.

Arms & Interventions

Arms

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).

Interventions

Dietary Supplement: - IDOFORM®Travel

Four capsules IDOFORM®Travel orally every 24 hour (12*10^9 cfu/day) for eight weeks.

Contact a Trial Team

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International Sites

Oslo University Hospital, Oslo, Norway

Status

Recruiting

Address

Oslo University Hospital

Oslo, ,

Site Contact

Jonas Andre Lundekvam, MD

joalun@ous-hf.no

004723015981

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