Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
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ClinicalTrials.gov Identifier: NCT00268164 |
Recruitment Status :
Terminated
(Inclusion was difficult and to slow)
First Posted : December 22, 2005
Last Update Posted : May 6, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |

- Number of patients with relapse at 12 month.
- Number of days to relapse.
- Presence and concentrations of the probiotic bacterial strains in stool.
- Safety and tolerance of the probiotic mixture.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

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): NCT00268164
Denmark | |
Dept. of Medical Gastroenterology | |
Hvidovre, Denmark, 2650 |
Study Chair: | Flemming Bendtsen, MD, DMSci | Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark |
ClinicalTrials.gov Identifier: | NCT00268164 |
Other Study ID Numbers: |
AB coul |
First Posted: | December 22, 2005 Key Record Dates |
Last Update Posted: | May 6, 2015 |
Last Verified: | September 2006 |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |