NCT01765439

Brief Summary

The aim of the study is to determine, whether administration of VSL#3 (Original De Simone formulation) probiotic preparation can alter the bile acid metabolism in patients with inflammatory bowel disease.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Feb 2014Dec 2027

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

13.5 years

First QC Date

January 7, 2013

Last Update Submit

April 21, 2026

Conditions

Crohn DiseaseUlcerative Colitis

Keywords

bile acidsmetabolismprobiotics

Outcome Measures

Primary Outcomes (1)

  • Alteration in the rate of bile acid synthesis

    Will be assessed as difference between serum levels of fibroblast growth factor 19 and C4 at baseline and 6 weeks, respectively.

    Baseline and 6 weeks (plus or minus 5 days)

Secondary Outcomes (2)

  • Change of the spectrum of bile acids in stools and plasma

    Baseline and 6 weeks (plus or minus 5 days).

  • Change of a metabolomic profile in urine

    Baseline and 6 weeks (plus or minus 5 days).

Other Outcomes (1)

  • Change of the disease activity

    Baseline and 6 weeks (plus or minus 5 days).

Study Arms (4)

CD resected

EXPERIMENTAL

Patients with Crohn´s disease with the history of single resection (\<60 cm) of distal leum.

Dietary Supplement: VSL#3 (Original De Simone formulation)

UC unoperated

EXPERIMENTAL

Patients with ulcerative colitis without history of gut resection.

Dietary Supplement: VSL#3 (Original De Simone formulation)

UC IPAA

EXPERIMENTAL

Patients with ulcerative colitis after proctocolectomy and ileal pouch-anal anastomosis(IPAA).

Dietary Supplement: VSL#3 (Original De Simone formulation)

Healthy volunteers

EXPERIMENTAL

Subjects without any sign of disease of the digestive tract.

Dietary Supplement: VSL#3 (Original De Simone formulation)

Interventions

VSL#3 (Original De Simone formulation)DIETARY_SUPPLEMENT

Study subjects will receive two sachets of VSL#3 probiotic (ie 2x900 billions of live bacteria) per day (one in the morning, one in the evening). The intervention period will be 6 weeks (plus or minus 5 days).

CD resectedHealthy volunteersUC IPAAUC unoperated

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Arm CD resected
  • confirmed diagnosis of Crohn´s disease (at least 6 months)
  • maximum length of resected ileum is 60 cm
  • no signs of disease activity (clinical, endoscopical, laboratory)
  • stable medication
  • Arm UC unoperated
  • confirmed diagnosis of ulcerative colitis (at least 6 months)
  • no signs of disease activity (clinical, endoscopical, laboratory)
  • stable medication
  • Arm UC IPAA
  • confirmed diagnosis of ulcerative colitis (at least 6 months)
  • no signs of disease activity (clinical, endoscopical, laboratory)
  • stable medication
  • Arm Healthy volunteers
  • no signs of gastrointestinal disorder
  • +1 more criteria

You may not qualify if:

  • use of bile acids
  • use of bile acids sequestrants
  • use of farnesoid X receptor agonists/antagonists
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iscare I.V.F.

Prague, 17004, Czechia

Location

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Martin Lenicek, MD, Ph.D.

    Charles University, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 10, 2013

Study Start

February 1, 2014

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

CZ(1)