NCT03798210: COLUS

Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis

Status unknown Phase 2 Last updated 14 January 2019

What this trial tests

Phase 2 trial testing Lactobacillus reuteri in Ulcerative Colitis Flare in 40 participants. Status unknown.

Timeline

1 January 2017

Primary endpoint
31 January 2019

1 March 2019

Quick facts

Lead sponsor	Uppsala University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	40
Start date	1 January 2017
Primary completion	31 January 2019
Estimated completion	1 March 2019
Sites	1 location across Sweden

Drugs / interventions tested

• Lactobacillus reuteri
• Placebo

Conditions studied

• Ulcerative Colitis Flare — all drugs for Ulcerative Colitis Flare →

Sponsor

Uppsala University

Who can join

Adults 18 to 80, any sex, with Ulcerative Colitis Flare. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Natural compounds as safe therapeutic options for ulcerative colitis.
   Gupta M, Mishra V, Gulati M, Kapoor B, et al · · 2022 · cited 55× · PMID 35212849 · DOI 10.1007/s10787-022-00931-1
2. Probiotics for maintenance of remission in ulcerative colitis.
   Iheozor-Ejiofor Z, Kaur L, Gordon M, Baines PA, et al · · 2020 · cited 53× · PMID 32128794 · DOI 10.1002/14651858.cd007443.pub3
3. Natural approaches for the management of ulcerative colitis: evidence of preclinical and clinical investigations.
   Subudhi RN, Poonia N, Singh D, Arora V. · · 2024 · cited 14× · PMID 39078427 · DOI 10.1007/s13659-024-00463-x
4. Engineered Probiotic-Based Biomaterials for Inflammatory Bowel Disease Treatment.
   Sang G, Wang B, Xie Y, Chen Y, et al · · 2025 · cited 9× · PMID 40093907 · DOI 10.7150/thno.103983