The effect of dried chicory root on inflammation, gut microbiota and complaints in patients with Inflammatory Bowel Disease: a pilot study
- Conditions
- Crohn's diseaseIBD10017969
- Registration Number
- NL-OMON56552
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
- Men and women aged >=18 years;
- Having a diagnosis of IBD (either UC or CD) and undergoing treatment at the
outpatient at UMCG;
- Mild or moderate IBD, defined as fecal calprotectin levels >=100 µg/ gram
faeces and Harvey Bradshaw Index (HBI) <8 for CD patients or Simple Clinical
Colitis Activity Index (SCCAI) <5 for CU patients;
- Using stable maintenance therapy for at least 12 weeks;
- Being able to read and speak Dutch;
- Willing to come to the UMCG for practical reasons (visiting the study site);
- Willing to continue their regular lifestyle patterns during the study.
- 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 synbiotics (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective:<br /><br>To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on<br /><br>fecal calprotectin levels in patients with CD and UC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objective(s):<br /><br>- To explore the effect of a 4-week WholeFiberTM intervention on stool pattern,<br /><br>IBD-complaints and QoL in patients with CD and UC.<br /><br>- To explore the effect of a 4-week WholeFiberTM intervention on fecal<br /><br>microbiota composition, SCFA levels, fecal pH and redox status in patients with<br /><br>CD and UC.<br /><br>- To explore the effect of a 4-week WholeFiberTM intervention on serum markers<br /><br>in IBD in patients with CD and UC.<br /><br>- How is the use of WholeFiberTM evaluated by patients with CD and UC?<br /><br>- Is there a difference in effect of WholeFiberTM between patients with CD and<br /><br>UC?</p><br>