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We recruited 25 of the 40 participants from intended study population. Recruitment in new populations requires an METC amendment.
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RATIONALE: 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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | Multispecies probiotic product Ecologic 825, 2x10-9 colony forming units per gram, 6 grams per day. |
|
| Placebo | Placebo Comparator | Similar in appearance as the probiotics, but not containing any bacteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecologic 825 | Dietary Supplement | Multispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal permeability measured by the Lactulose Mannitol test (L/M test) | Measured by the Lactulose Mannitol ratio in urine (L/M test) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood CRP levels | inflammatory marker | 6 and 12 weeks |
| fecal calprotectin levels | marker of intestinal inflammation | 6 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole De Roos, PhD | Wageningen UR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelderse Vallei Hospital | Ede | Netherlands |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Dietary Supplement | Placebo |
|
| Quality of life (measured by IBD-Q and SF36) | Disease related quality of life will be measured by IBD-Q and SF36 | 6 and 12 weeks |
| Intestinal permeability measured by the Lactulose Mannitol test (L/M test) | Measured by the Lactulose Mannitol ratio in urine (L/M test) | 6 weeks |
| Lipopolysaccharides levels in blood | A marker for intestinal permeability and inflammation | 6 and 12 weeks |
| Intestinal permeability measured by faecal zonulin levels | Measured by faecal zonulin levels | 6 and 12 weeks |
| microbiota composition | measured by human intestinal tract (HIT-chip) microarray | 6 and 12 weeks |
| interferon gamma levels | measured in plasma samples | 6 and 12 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |