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 intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber). Researchers will compare the above mentioned outcomes before and after the intervention.
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 and severely impacts quality of life (QoL), leads to more hospitalization and increases the mortality risk. An impaired gut microbiota and lower levels of short-chain fatty acids (SCFA) have been linked to the pathophysiology. A higher fiber intake is linked to positive changes in the gut microbiota and increase SCFA-production, however patients with IBD consume too little dietary fiber. WholeFiberTM, a dried vegetable rich in 4 types of prebiotic fiber, may be an easy solution to increase dietary fiber intake, impact the gut microbiota and SCFA, IBD-complaints and health parameters. Objective: To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with CD and UC. Study design: this is a 4-week pilot study with one arm to explore the effects of a WholeFiberTM intervention. Measurements will take place before and after the intervention, questionnaires will also be conducted halfway. Study population: in total 12 patients with mild to moderate IBD complaints will be included, of which 6 UC and 6 CD patients, to investigate if there is a difference between the two groups in efficacy of WholeFiberTM. Intervention: Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber). Main study parameters/endpoints: the primary parameter is change in fecal calprotectin after the 4-week intervention, which is a marker for inflammation in the gut. Secondary parameters are improvements in IBD-complaints, QoL, serum markers, and changes in the gut microbiota and increase in fecal SCFA-production. Moreover, it will be explored whether the response on the intervention will be different between UC and CD. Furthermore, an evaluation questionnaire will be conducted to assess feasibility and acceptance of the WholeFiberTM intervention in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber). WholeFiberTM is a fiber-rich dried vegetable made from the chicory root that contains four types of prebiotic fibers (inulin, pectin, cellulose, hemi-cellulose).
University Medical Center Groningen
Groningen, Netherlands
change in fecal calprotectin
To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels in patients with CD and UC.
Time frame: difference between baseline and after 4-week intervention
Change in IBD complaints by HBI for CD
To explore the effect of a 4-week WholeFiberTM intervention on IBD-complaints in patients with CD measured by the Harvey Bradshaw Index (HBI)
Time frame: difference between baseline and after 4-week intervention
Change in IBD complaints by SCCAI for UC
To explore the effect of a 4-week WholeFiberTM intervention on IBD-complaints in patients UC measured by the Simple Clinical Colitis Activity Index (SCCAI)
Time frame: difference between baseline and after 4-week intervention
Change in QOL measured by IBDQ
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on QoL measured by the IBDQ (Irvine 1999)
Time frame: difference between baseline and after 4-week intervention
Change in the Food-related Quality of Life (FrQOL)
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Food-related QoL measured by a validated instrument by Hughes et al 2015
Time frame: difference between baseline and after 4-week intervention
Change in stool consistency
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on stool consistency. Stool consistency will be measured using the validated Bristol Stool Chart.
Time frame: difference between baseline and after 4-week intervention
Change in stool frequency
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on stool frequency. Patients will be asked how often they defecated per day during the past week
Time frame: difference between baseline and after 4-week intervention
Change in fecal microbiota composition: Shannon-index
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal microbiota composition. Next generation sequencing will be used ot determine bacterial richness (Shannon-index)
Time frame: difference between baseline and after 4-week intervention
Change in fecal microbiota composition by beta-diversity
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal microbiota composition. Next generation sequencing will be used ot determine bacterial interindividual variations (beta-diversity)
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: lactate
To explore the effect of a 4-week WholeFiberTM intervention on fecal lactate in patients with CD and UC measured by a conductivity detector.
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: formate
To explore the effect of a 4-week WholeFiberTM intervention on fecal formate in patients with CD and UC measured by a conductivity detector.
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels; butyrate
To explore the effect of a 4-week WholeFiberTM intervention on fecal butyrate in patients with CD and UC measured by a conductivity detector.
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: propionate
To explore the effect of a 4-week WholeFiberTM intervention on fecal propionate in patients with CD and UC measured by a conductivity detector.
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: acetate
To explore the effect of a 4-week WholeFiberTM intervention on fecal acetate in patients with CD and UC measured by a conductivity detector.
Time frame: difference between baseline and after 4-week intervention
Change in fecal acidity (pH)
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal acidity (pH) by a PCE-228-R pH and redox meter in a stool sample.
Time frame: difference between baseline and after 4-week intervention
Change in fecal redox status
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal redox status, measured by PCE-228-R instrument.
Time frame: difference between baseline and after 4-week intervention
Change in serum leukocytes
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on leukocytes count.
Time frame: difference between baseline and after 4-week intervention
Change in serum thrombocytes
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on thrombocytes.
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: serum iron
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC serum iron \[micromol/L\]
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: Total Iron Binding Capacity (TIBC)
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Total Iron Binding Capacity (TIBC) \[micromol/L\]
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: ferritin
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on ferritin \[microg/L\]
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: transferrin
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on transferrin \[g/L\]
Time frame: difference between baseline and after 4-week intervention
Change in serum ALAT
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Alanine Aminotransferase (ALAT).
Time frame: difference between baseline and after 4-week intervention
Change in serum ASAT
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Aspartate Aminotransferase (ALAT).
Time frame: difference between baseline and after 4-week intervention
Change in serum GGT
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Gamma-Glutamyl Transferase (GGT)
Time frame: difference between baseline and after 4-week intervention
Change in serum creatinine
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on iron status.
Time frame: difference between baseline and after 4-week intervention
Change in C-reactive protein (CRP)
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on C-reactive protein (CRP), which is an inflammation marker.
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-6 analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-6 on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-8 analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-8 on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-10 analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-10 on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory markers IL-12 analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-12 on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory markerIL-17a analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-17a on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-22 analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-22 on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-23 analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-23 on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker TNF-alpha analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker TNF-alpha on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker Interferon(IFN)-gamma analysed by an ELISA kit
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker Interferon(IFN)-gamma on an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in oxidative stress measured by free thiols
To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on oxidative stress measured by free thiols.
Time frame: difference between baseline and after 4-week intervention
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