Boosting Biologics in UC

NCT04241029 | Completed

• 1 other identifier: 2016/2269
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (3)

• Adverse events

  Unit of Measure: Frequency

  8 weeks

• 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)

  8 weeks

• 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

  12 weeks

Secondary Outcomes (3)

• Alterations in mucosa-adherent microbial composition

  8 weeks

• Alterations in epithelial gene expression

  8 weeks

• Alterations in markers of chronic inflammation / immune activation

  8 weeks

Study Arms (1)

Intervention with probiotics

EXPERIMENTAL

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

Interventions

IDOFORM®Travel DIETARY_SUPPLEMENT

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

Intervention with probiotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Sor-Ost: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Asle Medhus, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of dep. of Gastroenterology, OUH. MD, PhD.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 27, 2020
• Study Start: February 25, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NO (1)