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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
Information provided by (Responsible Party):
Wageningen University

Brief Summary:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. blood CRP levels [ Time Frame: 6 and 12 weeks ]
    inflammatory marker

  2. fecal calprotectin levels [ Time Frame: 6 and 12 weeks ]
    marker of intestinal inflammation

  3. 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

  4. 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)

  5. Lipopolysaccharides levels in blood [ Time Frame: 6 and 12 weeks ]
    A marker for intestinal permeability and inflammation

  6. Intestinal permeability measured by faecal zonulin levels [ Time Frame: 6 and 12 weeks ]
    Measured by faecal zonulin levels

  7. microbiota composition [ Time Frame: 6 and 12 weeks ]
    measured by human intestinal tract (HIT-chip) microarray

  8. interferon gamma levels [ Time Frame: 6 and 12 weeks ]
    measured in plasma samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed Ulcerative Colitis (left sided UC or pancolitis)
  • 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:

  • 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

Information from the National Library of Medicine

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
Ede, Netherlands
Sponsors and Collaborators
Wageningen University
Principal Investigator: Nicole De Roos, PhD Wageningen UR

Additional Information:
Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02361957     History of Changes
Other Study ID Numbers: NL46674.081.13
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases