NL-OMON28957
Recruiting
Not Applicable
A randomized controlled trial to investigate the efficacy of a multispecies probiotic supplement (Ecologic® BARRIER) on symptoms of fatigue in subjects with Inflammatory Bowel Disease
Winclove B.V.0 sites230 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Winclove B.V.
- Enrollment
- 230
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects between the ages of 18 and 65 years old.
- •Subjects diagnosed with Crohn’s disease or Ulcerative Colitis.
- •Subjects with a score of 4 or higher on the Chalder Fatigue Questionnaire.
Exclusion Criteria
- •Subjects with active inflammation. Disease has to be in remission defined as CRP \= 10 mg/l, leucocytes between 4\.0\-10\.0 10E9/l and calprotectin levels of \= 100 µg/g.
- •Subjects with abnormal laboratory values, including but not limited to hemoglobin, vitamin B12 and folic acid levels. These need to be corrected and retested before entering the study.
- •Subjects who used probiotics (including probiotic\-containing products such as Yakult, Actimel, etc), antibiotics or Non\-Steroidal Anti\- Inflammatory Drugs (NSAIDs) in the 4 weeks prior to the screening visit, or are planning to do so during the study.
- •Subjects with local manifestation of IBD for which surgery might be indicated or which could confound the evaluation of efficacy.
- •Subjects who have had placement of a stoma or pouch.
- •Subjects who are pregnant, lactating or planning pregnancy while enrolled in the study.
- •Subjects who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject’s safety or confound data interpretation.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
A randomized controlled trial to investigate the efficacy of a multispecies probiotic supplement (Ecologic® BARRIER) on symptoms of fatigue in subjects with Inflammatory Bowel Diseasechronic bowel inflammationinflammatory bowel disease10017969NL-OMON55158Elisabeth-Tweesteden ziekenhuis220
Completed
Not Applicable
The effectiveness of regular back movements in preventing children from getting back paiow back pain in childrenLow back pain in childrenMusculoskeletal - Other muscular and skeletal disordersACTRN12611000551998Julia Hill750
Completed
Phase 3
The effect of rehabilitation exercises on balance in patients with chronic strokeStroke.Stroke, not specified as haemorrhage or infarctionIRCT2017071916830N7Vice Chancellor for research, Iran University of Medical Sciences40
Completed
Not Applicable
Addition of low dose primaquine to artemether-lumefantrine for the treatment of uncomplicated malariaMalariaPACTR201611001859416niversity of Cape Town140
Completed
Not Applicable
A randomised controlled trial to investigate the effect of regular moderate intensity exercise on plasma fibrinogen in people with type two diabetes: a pilot studyType two diabetesNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitusISRCTN98564438Department of Health80