Status:
UNKNOWN
Dried Chicory Root in IBD
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
WholeFiber
MyMicroZoo
Conditions:
Inflammatory Bowel Diseases
Dietary Exposure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical pilot trial is to test the use of dried chicory root in patients with IBD. The main questions it aims to answer are: what the effect of a 4-week 10-20 g/day WholeFiberTM int...
Detailed Description
Rationale: Inflammatory Bowel Diseases (IBD), of which Ulcerative Colitis (UC) and Crohn's Disease (CD) are the main types, includes recurring episodes of inflammation in the gastro-intestinal tract a...
Eligibility Criteria
Inclusion
- Men and women aged ≥18 years;
- Having a diagnosis of IBD (either UC or CD) and undergoing treatment at the policlinic at the University Medical Center Groningen;
- Mild or moderate IBD, defined as fecal calprotectin levels ≥100 μg and Harvey Bradshaw Index (HBI) \<8 for CD patients or Simple Clinical Colitis Activity Index (SCCAI) \<5 for UC patients;
- Using stable maintenance therapy for at least 12 weeks;
- Being able to read and speak Dutch;
- Willing to come to the University Medical Center Groningen for practical reasons (visiting the study site);
- Willing to continue their regular lifestyle patterns during the study.
Exclusion
- Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, cancer, celiac disease;
- Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbiota composition;
- Having a clinically significant stenosis;
- Use of antibiotics \<4 weeks before study start;
- Use of prebiotics, probiotics and/or synbiotic (this should be stopped 4 weeks before start of the study) or other fiber supplements such as psyllium;
- Use of tube feeding or sib-feeding;
- Being pregnant or lactating;
- Participation in another clinical study at the same time;
- Unable or unwilling to comply to study rules
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06016322
Start Date
October 2 2023
End Date
September 30 2024
Last Update
September 21 2023
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ