The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients

Phase

N/A

Condition

Inflammatory Bowel Disease

Colic

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT02361957

NL46674.081.13

Ages 18-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 systemicsteroids, immunosuppressive drugs or aspirin) one week prior the first baselinemeasurement.
Use of other pre- and probiotics and not willing to stop these 2 weeks before theintervention 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 pregnantduring the study
Patients foreseen to need GI surgery during the study period
Patients with a history of cancer

Study Design

November 01, 2014

December 31, 2015

Connect with a study center

Gelderse Vallei Hospital
Ede,
Netherlands
Site Not Available

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