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Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis (COLUS)

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ClinicalTrials.gov Identifier: NCT03798210
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Per Hellström, Uppsala University

Brief Summary:

Explorative investigation to study the effect of the endogenous bacterium Lactobacillus reuteri ATCC PTA 4659 as a nutrient additive against relapse in ulcerative colitis. Forty patients will be studied with a randomized parallel design over one year. Patients with established treatment against relapse of ulcerative colitis with mesalazine ≤4 grams will be requested to participate in the study, allocated to 20 patients with placebo and 20 with active treatment L. reuteri as an "add-on". Inklusion: 18-80 years of age, ≥1 relapse with bleeding during previous 12 months with a disease activity Mayo Clinical Score ≤2, treatment with mesalazine ≤4,0 g daily. Exklusion: >80 years of age, no registered bleeding during recent 12 months, on-going steroid treatment, immunosuppressives, biologics or adhesion inhibitors, antibiotics or other clinical trial. behandling med probiotika. Disease monitoring will be done with:

Time to disease relapse with macroscopic bleeding and Mayo score ≥5, blood chemistry and CRP, lipopolysaccharides and gut permeability, fecal calprotectin, and short health scale at 4 weeks, 26 weeks and 52 weeks.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Flare Dietary Supplement: Lactobacillus reuteri Dietary Supplement: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Lactobacillus reuteri versus placebo on prevention of flare in ulcerative colitis/proctosgmoiditis
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Pre-masked randomized tablet vials with Lactobacillus reuteri, or corresponding placebo
Primary Purpose: Prevention
Official Title: The Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative Colitis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Look and taste-alike placebo tablets in white plastic vials.
Dietary Supplement: Placebo
Placebo

Experimental: Lactobacillus reuter's
Lactobacillus reuteri tablets in white plastic vials.
Dietary Supplement: Lactobacillus reuteri
Study group split in two arms for experimental treatment with Lactobacillus reuteri or placebo.




Primary Outcome Measures :
  1. Rectal bleeding with Mayo score ≥5 [ Time Frame: 12 months ]
    Rectal bleeding as sign of increased inflammatory activity as determined by the Mayor Clinic Score for evaluation of disease activity in ulcerative colitis


Secondary Outcome Measures :
  1. Increased fecal calprotectin [ Time Frame: 12 months ]
    Gut inflammatory biomarker

  2. Increased CRP [ Time Frame: 12 months ]
    General inflammatory biomarker


Other Outcome Measures:
  1. Serum Zonulin [ Time Frame: 12 months ]
    Gut permeability biomarker

  2. Gut permeability [ Time Frame: 12 months ]
    Recovery of sugar molecules in urine as marker of increased permeability



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of UC confirmed by biopsy
  • Mayo full score < 2
  • Total or left-sided UC
  • Stable diagnose of UC >1 year
  • History of more than 1 yearly recurrence
  • Current remission period exceeding 2 months
  • 18-75 years of age
  • Baseline 5-ASA ≤2g daily
  • Mentally fit to participate
  • Informed consent obtained

Exclusion Criteria:

  • Crohn's disease
  • Ulcerative proctitis
  • Infective colitis
  • Liver disease
  • Current use of probiotics
  • Current medication acetylsalicylic acid (ASA), non-steroidal antiinflammatory drugs (NSAID), corticosteroids, anticoagulants, serotonin-selective re-uptake inhibitors (SSRI), serotonin-noradrenaline re-uptake inhibitors (SNRI), azathioprine (AZA), 6-mercaptopurin (6-MP), thioguanin (TG), anti-TNF-alpha biologicals
  • Participation in other clinical trials

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): NCT03798210


Contacts
Contact: Per M Hellström, Prof +46 70 3727423 per.hellstrom@medsci.uu.se
Contact: Peter Benno, MD, PhD +46 70 579554 peter.benno@endoskopienheten.se

Locations
Sweden
Uppsala University Recruiting
Uppsala, Sweden, 75185
Contact: Per M Hellström, Prof    +46 70 3727423    per.hellstrom@medsci.uu.se   
Contact: Peter Benno, MD, PhD    +46 70 5795554    peter.benno@endoskopienheten.se   
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Per M Hellström, Prof Uppsala University

Responsible Party: Per Hellström, Prof, MD, PhD, Uppsala University
ClinicalTrials.gov Identifier: NCT03798210     History of Changes
Other Study ID Numbers: ATCC PTA 4659
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Shared at publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Per Hellström, Uppsala University:
ulcerative colitis
prevention
microbiota
Lactobacillus

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases