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
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|
|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|
|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|
Placebo Comparator: Placebo
Look and taste-alike placebo tablets in white plastic vials.
Dietary Supplement: 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.
- 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
- Increased fecal calprotectin [ Time Frame: 12 months ]Gut inflammatory biomarker
- Increased CRP [ Time Frame: 12 months ]General inflammatory biomarker
- Serum Zonulin [ Time Frame: 12 months ]Gut permeability biomarker
- Gut permeability [ Time Frame: 12 months ]Recovery of sugar molecules in urine as marker of increased permeability
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
|Contact: Per M Hellström, Prof||+46 70 email@example.com|
|Contact: Peter Benno, MD, PhD||+46 70 firstname.lastname@example.org|
|Uppsala, Sweden, 75185|
|Contact: Per M Hellström, Prof +46 70 3727423 email@example.com|
|Contact: Peter Benno, MD, PhD +46 70 5795554 firstname.lastname@example.org|
|Principal Investigator:||Per M Hellström, Prof||Uppsala University|