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TerminatedNCT00268164Updated May 6, 2015

Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

A Phase 2 interventional study of lactobacilus acidophilus & bifidobacterium animalis/lactis in Ulcerative Colitis, sponsored by Hvidovre University Hospital. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by Hvidovre University Hospital · Phase 2, Interventional, and Treatment

Why this study was terminated
Inclusion was difficult and to slow
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy and lactating
  • Serious underlying disease other than UC
  • Former gastrointestinal resections
  • Medication for UC other than mesalazine
  • Known allergic reactions towards compounds in the study drug.
  • Expected lack of compliance due to mental state or language problems
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
48 participants

Interventions

  • Druglactobacilus acidophilus & bifidobacterium animalis/lactis
06

What researchers measure

Primary outcomes

  1. Number of patients with relapse at 12 month.

Secondary outcomes

  1. Number of days to relapse.

  2. Presence and concentrations of the probiotic bacterial strains in stool.

  3. Safety and tolerance of the probiotic mixture.

07

Study locations

1 site
  • Dept. of Medical Gastroenterology
    Hvidovre, 2650, Denmark
08

References and documents

Publications

  • Wildt S, Nordgaard I, Hansen U, Brockmann E, Rumessen JJ. A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. J Crohns Colitis. 2011 Apr;5(2):115-21. doi: 10.1016/j.crohns.2010.11.004. Epub 2011 Jan 8. Erratum In: J Crohns Colitis. 2023 Jan 27;17(1):149. doi: 10.1093/ecco-jcc/jjac104. PubMed 21453880 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00268164
Lead sponsor
Hvidovre University Hospital
Collaborators
Chr Hansen
First posted
Dec 22, 2005
Start date
Jun 2004
Primary completion
Mar 2007
Completion
Mar 2007
Last update
May 6, 2015

Study contacts

Flemming Bendtsen, MD, DMSci
study chair · Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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