The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients
NCT ID: NCT02361957
Last Updated: 2015-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
40 participants
INTERVENTIONAL
2014-11-30
2015-12-31
Brief Summary
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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.
STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in remission or mild stage of the disease. For inclusion of the patients the Patient Simple Clinical Colitis Activity Index (P-SCCAI) will be used.
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).
MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood serum and faecal zonulin. Secondary, 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Probiotics
Multispecies probiotic product Ecologic 825, 2x10-9 colony forming units per gram, 6 grams per day.
Ecologic 825
Multispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day
Placebo
Similar in appearance as the probiotics, but not containing any bacteria.
Placebo
Placebo
Interventions
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Ecologic 825
Multispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-65 (because microbiota change at older age)
* Stable disease activity (clinical remission with CRP levels \<10mg/L and calprotectin \<100 ug/g) as measured at baseline
* Mild disease activity (P-SCCAI \<5)
* Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Wageningen University
OTHER
Responsible Party
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Principal Investigators
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Nicole De Roos, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen UR
Locations
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Gelderse Vallei Hospital
Ede, , Netherlands
Countries
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Other Identifiers
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NL46674.081.13
Identifier Type: -
Identifier Source: org_study_id
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