NCT03798210

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

January 7, 2019

Last Update Submit

January 10, 2019

Conditions

Ulcerative Colitis Flare

Keywords

ulcerative colitispreventionmicrobiotaLactobacillus

Outcome Measures

Primary Outcomes (1)

  • Rectal bleeding with Mayo score ≥5

    Rectal bleeding as sign of increased inflammatory activity as determined by the Mayor Clinic Score for evaluation of disease activity in ulcerative colitis

    12 months

Secondary Outcomes (2)

  • Increased fecal calprotectin

    12 months

  • Increased CRP

    12 months

Other Outcomes (2)

  • Serum Zonulin

    12 months

  • Gut permeability

    12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Look and taste-alike placebo tablets in white plastic vials.

Dietary Supplement: Placebo

Lactobacillus reuter's

EXPERIMENTAL

Lactobacillus reuteri tablets in white plastic vials.

Dietary Supplement: Lactobacillus reuteri

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

Study group split in two arms for experimental treatment with Lactobacillus reuteri or placebo.

Lactobacillus reuter's
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age
  • Baseline 5-ASA ≤2g daily
  • Mentally fit to participate
  • Informed consent obtained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Per M Hellström, Prof

    Uppsala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per M Hellström, Prof

CONTACT

+46 70 3727423per.hellstrom@medsci.uu.se

Peter Benno, MD, PhD

CONTACT

+46 70 579554peter.benno@endoskopienheten.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Pre-masked randomized tablet vials with Lactobacillus reuteri, or corresponding placebo
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Lactobacillus reuteri versus placebo on prevention of flare in ulcerative colitis/proctosgmoiditis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, MD, PhD

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

January 1, 2017

Primary Completion

January 31, 2019

Study Completion

March 1, 2019

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

SE(1)