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| ID | Type | Description | Link |
|---|---|---|---|
| KIEM.K23.01.148 | Other Grant/Funding Number | NWO |
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| Name | Class |
|---|---|
| WholeFiber | UNKNOWN |
| MyMicroZoo | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before and after study in 6 patients with UC and 6 patients wiht CD | Experimental | This is a 4-week before-after pilot study to explore the effectiveness of a WholeFiber Trademark (TM) intervention (a dried vegetable rich in prebiotic intrinsic fibers) on inflammation, fecal gut microbiota and metabolites, IBD-complaints and QoL and assesses its feasibility. In this before-after study, 12 patients with IBD will receive WholeFiberTM; of which 6 patients with CD and 6 patients with UC to assess if there is a difference in effect between these groups of patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dried Chicory Root | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | difference between baseline and after 4-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | difference between baseline and after 4-week intervention |
| Change in IBD complaints by SCCAI for UC |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in fecal calprotectin between patients with CD and UC | To explore the difference between CD an UC in change in the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels | difference between baseline and after 4-week intervention |
| Appreciation of WholeFiberTM evaluated by patients with CD and UC? |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32199025 | Result | Puhlmann ML, de Vos WM. Back to the Roots: Revisiting the Use of the Fiber-Rich Cichorium intybusL. Taproots. Adv Nutr. 2020 Jul 1;11(4):878-889. doi: 10.1093/advances/nmaa025. | |
| 34486663 | Result | Peters V, Dijkstra G, Campmans-Kuijpers MJE. Are all dietary fibers equal for patients with inflammatory bowel disease? A systematic review of randomized controlled trials. Nutr Rev. 2022 Apr 8;80(5):1179-1193. doi: 10.1093/nutrit/nuab062. |
| Label | URL |
|---|---|
| Dried Chicory Root Improves Bowel Function, Benefits Intestinal Microbial Trophic Chains and Increases Faecal and Circulating Short Chain Fatty Acids in Subjects at Risk for Type 2 Diabetes | View source |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Pilot study investigating the effect of additional dietary intake 10-20 gram of a dried vegetable fibre. The difference in outcomes before and after the intervention in fecal calprotectin, IBD complaints, QOL, serum inflammatory markers, gut microbiota and SCFA will be determined
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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) |
| 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) | 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 | 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. | 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 | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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] | 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] | 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] | 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] | 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). | 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). | 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) | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | difference between baseline and after 4-week intervention |
How participants with CD and UC appreciated of WholeFiberTM by chosing a digit on a vascale from 1 to 10, being 1 the lowest number of appreciation and 10 the highest number |
| after 4-week intervention |
| The convenience of the use of WholeFiberTM evaluated by patients with CD and UC? | Participants are asked to rate the following statement "I find Whole Fiber easy to use" and can answer on a Lickert with 5 different categories: 1. completely disagree 2. disagree 3. neutral, 4 agree 5. completely agree. | after 4-week intervention |
| The palatability of the use of WholeFiberTM evaluated by patients with CD and UC? | Participants are asked to rate the following statement "I find Whole Fiber tasty to eat" and can answer on a Lickert with 5 different categories: 1. completely disagree 2. disagree 3. neutral, 4 agree 5. completely agree. | after 4-week intervention |
| 36059540 | Result | Puhlmann ML, de Vos WM. Intrinsic dietary fibers and the gut microbiome: Rediscovering the benefits of the plant cell matrix for human health. Front Immunol. 2022 Aug 18;13:954845. doi: 10.3389/fimmu.2022.954845. eCollection 2022. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |