The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients (CUPIDO)
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|ClinicalTrials.gov Identifier: NCT02361957|
Recruitment Status : Suspended (We recruited 25 of the 40 participants from intended study population. Recruitment in new populations requires an METC amendment.)
First Posted : February 12, 2015
Last Update Posted : August 28, 2015
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.
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis||Dietary Supplement: Ecologic 825 Dietary Supplement: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Probiotics
Multispecies probiotic product Ecologic 825, 2x10-9 colony forming units per gram, 6 grams per day.
Dietary Supplement: Ecologic 825
Multispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day
Other Name: PRO.IB
Placebo Comparator: Placebo
Similar in appearance as the probiotics, but not containing any bacteria.
Dietary Supplement: Placebo
- Intestinal permeability measured by the Lactulose Mannitol test (L/M test) [ Time Frame: 12 weeks ]Measured by the Lactulose Mannitol ratio in urine (L/M test)
- blood CRP levels [ Time Frame: 6 and 12 weeks ]inflammatory marker
- fecal calprotectin levels [ Time Frame: 6 and 12 weeks ]marker of intestinal inflammation
- Quality of life (measured by IBD-Q and SF36) [ Time Frame: 6 and 12 weeks ]Disease related quality of life will be measured by IBD-Q and SF36
- Intestinal permeability measured by the Lactulose Mannitol test (L/M test) [ Time Frame: 6 weeks ]Measured by the Lactulose Mannitol ratio in urine (L/M test)
- Lipopolysaccharides levels in blood [ Time Frame: 6 and 12 weeks ]A marker for intestinal permeability and inflammation
- Intestinal permeability measured by faecal zonulin levels [ Time Frame: 6 and 12 weeks ]Measured by faecal zonulin levels
- microbiota composition [ Time Frame: 6 and 12 weeks ]measured by human intestinal tract (HIT-chip) microarray
- interferon gamma levels [ Time Frame: 6 and 12 weeks ]measured in plasma samples
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): NCT02361957
|Gelderse Vallei Hospital|
|Principal Investigator:||Nicole De Roos, PhD||Wageningen UR|