To investigate whether a specifically designed multispecies probiotic mixture (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal permeability, microbiota composition, disease activity and inflammatory markers in…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is intestinal permeability measured by several
techniques: the Multi Sugar Absorption test in 24-h urine, zonulin in faeces
and in serum.
Secondary outcome
Inflammation will be measured from faecal calprotectin and blood c-reactive
protein (CRP) levels. Furthermore samples will be stored to measure cytokine
concentrations in serum and to analyse the microbial composition of the faecal
samples using the HITchip. For the disease related quality of life the
irritable bowel disease questionnaire (IBD-Q) and SF-36 will be used. All
parameters will be measured at three time points; t=0, t=6 and t=12 weeks.
Background summary
The underlying etiology in inflammatory bowel diseases such as Ulcerative
Colitis is not yet fully understood. Studies suggest a relation between higher
intestinal permeability and aberrant changes of the epithelium. Dysbiosis of
the intestinal microbiota might be the cause. Probiotics may restore the
balance of the intestinal microbiota. In theory this could improve intestinal
permeability and therefore reduce disease activity and maintain remission in
patients with Ulcerative Colitis.
Study objective
To investigate whether a specifically designed multispecies probiotic mixture
(ecologic 825®), as adjuvant therapy, can contribute to an improvement of
intestinal permeability, microbiota composition, disease activity and
inflammatory markers in ulcerative colitis.
Study design
12-wk placebo-controlled randomized double-blind intervention with 2 parallel
arms.
Intervention
Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two
daily doses of 3 g of the placebo, containing only the carrier material (both
produced by Winclove Probiotics).
Study burden and risks
The lactic acid bacteria in the mixture carry the European Union Qualified
Presumption of Safety (QPS) status. No side effects are expected. The probiotic
mixture is available on the Dutch market under the name PRO.IB. The product has
been used in pouchitis patients, without adverse effects. Measurements are
restricted to blood sampling, urine and faeces collection at 3 time points. The
probiotic treatment might be beneficial resulting in a better gut health which
could prolong the remission period and improve disease related quality of life.
Bomenweg 2
Wageningen 6703HD
NL
Bomenweg 2
Wageningen 6703HD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed Ulcerative Colitis (left sided UC or pancolitis)
- Age 18-65 (because microbiotia change at older age)
- Stable disease activity (clinical remission with CRP levels <10mg/L) as measured at baseline
- Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day
Exclusion criteria
- History of intestinal surgery that might interfere with the outcome of the study
- Diabetes Mellitus (medication dependent)
- Current use of antibiotics
- Current use of corticosteroids (30 days prior to the first baseline measurement).
- Treatment with other medication besides mesalazine (NSAIDs, topical or systemic steroids, immunosuppressive drugs or aspirin) one week prior the first baseline measurement.
- Use of other pre- and probiotics and not willing to stop these 2 weeks before the intervention period
- Hypersensitivity or allergy to milk protein, soy protein and gluten
- Alcohol abuse (male more than 14 servings a week, female more than 7 servings a week)
- Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
- Patients foreseen to need GI surgery during the study period
- Patients with a history of cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46674.081.13 |