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Synbiotic Treatment of Ulcerative Colitis Patients

Synbiotic Treatment of Ulcerative Colitis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00803829
Enrollment
24
Registered
2008-12-08
Start date
2009-01-31
Completion date
2011-01-31
Last updated
2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is associated with high morbidity and incurs significant social, commercial and NHS costs. For a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. However, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. The aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with active disease. It is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. If the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for UC, making a significant contribution to relieving the clinical and financial burdens of this disease.

Interventions

OTHERSynbiotic (Synergy1/B. longum)

Probiotic Bifidobacterium longum Prebiotic Synergy 1

Sponsors

National Association for Colitis and Crohn's Disease
CollaboratorOTHER
University of Dundee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Ulcerative colitis * Stable doses of medications for UC for the preceding three months * Mayo score of 6 to 12 * Sigmoidoscopy subscore of 2 * Stable doses of medication

Exclusion criteria

* Pregnancy * Lactation * Antibiotic therapy in the last three months * Probiotic or prebiotic therapy in the last month * Crohn's Disease, indeterminate colitis * Alterations to medications in the last three months

Design outcomes

Primary

MeasureTime frame
Reduction in mucosal TNF-alpha6 months

Secondary

MeasureTime frame
Induction of clinical remission measured by a reduction in Mayo disease activity score6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026