Inflammatory Bowel DiseasesChic-IBDNCT06016322
Dried Chicory Root in IBD
A study testing Dried Chicory Root in people with Inflammatory Bowel Diseases and Dietary Exposure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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 intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Dietary Exposure
- What is being tested?
- Dried Chicory Root
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- Being pregnant or lactating;
- Participation in another clinical study at the same time;
- Unable or unwilling to comply to study rules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dried Chicory Root on Inflammation, Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease: a Pilot Study
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.
Read the 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 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.
- Conditions
- Inflammatory Bowel Diseases, Dietary Exposure
- Being tested
- Dried Chicory Root
- Keywords
- Inflammatory bowel disease, dietary fiber, gut microbiome, inflammation
- Medical subject headings
- Inflammatory Bowel Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried Chicory RootDietary supplement
Also called WholeFiber Trademark (TM)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Dried Chicory Root |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: difference between baseline and after 4-week intervention
Secondary outcomes (36)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: difference between baseline and after 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start2 Oct 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- WholeFiber, MyMicroZoo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016322
- Sponsor's protocol ID
- NL85061.042.23
- Other IDs
- KIEM.K23.01.148
- Acronym
- Chic-IBD
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32199025Peters 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.
PubMed 34486663Puhlmann 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.
PubMed 36059540
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dried Chicory Root on Inflammation, Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT06016322
- Acronym / sponsor ID
- Chic-IBD / NL85061.042.23
- Conditions
- Inflammatory Bowel Diseases, Dietary Exposure
- Keywords
- Inflammatory bowel disease, dietary fiber, gut microbiome, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- WholeFiber, MyMicroZoo
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Before and after study in 6 patients with UC and 6 patients wiht CD | Experimental | Dietary Supplement: Dried Chicory RootThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried Chicory RootAlso: WholeFiber Trademark (TM)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). | Dietary supplement | Before and after study in 6 patients with UC and 6 patients wiht CD |
Primary outcome
change in fecal calprotectin
Time frame: difference between baseline and after 4-week intervention
To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels in patients with CD and UC.
36 secondary outcomes
Change in IBD complaints by HBI for CD
Time frame: difference between baseline and after 4-week intervention
Change in IBD complaints by SCCAI for UC
Time frame: difference between baseline and after 4-week intervention
Change in QOL measured by IBDQ
Time frame: difference between baseline and after 4-week intervention
Change in the Food-related Quality of Life (FrQOL)
Time frame: difference between baseline and after 4-week intervention
Change in stool consistency
Time frame: difference between baseline and after 4-week intervention
Change in stool frequency
Time frame: difference between baseline and after 4-week intervention
Change in fecal microbiota composition: Shannon-index
Time frame: difference between baseline and after 4-week intervention
Change in fecal microbiota composition by beta-diversity
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: lactate
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: formate
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels; butyrate
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: propionate
Time frame: difference between baseline and after 4-week intervention
Change in fecal SCFA levels: acetate
Time frame: difference between baseline and after 4-week intervention
Change in fecal acidity (pH)
Time frame: difference between baseline and after 4-week intervention
Change in fecal redox status
Time frame: difference between baseline and after 4-week intervention
Change in serum leukocytes
Time frame: difference between baseline and after 4-week intervention
Change in serum thrombocytes
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: serum iron
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: Total Iron Binding Capacity (TIBC)
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: ferritin
Time frame: difference between baseline and after 4-week intervention
Change in serum iron status: transferrin
Time frame: difference between baseline and after 4-week intervention
Change in serum ALAT
Time frame: difference between baseline and after 4-week intervention
Change in serum ASAT
Time frame: difference between baseline and after 4-week intervention
Change in serum GGT
Time frame: difference between baseline and after 4-week intervention
Change in serum creatinine
Time frame: difference between baseline and after 4-week intervention
Change in C-reactive protein (CRP)
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-6 analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-8 analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-10 analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory markers IL-12 analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory markerIL-17a analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-22 analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker IL-23 analysed by an ELISA kit
Time frame: difference between baseline and after 4-week intervention
Change in inflammatory marker TNF-alpha analysed by 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
Time frame: difference between baseline and after 4-week intervention
Change in oxidative stress measured by free thiols
Time frame: difference between baseline and after 4-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Results publication: PubMed 32199025Puhlmann 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.
- Results publication: PubMed 34486663Peters 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.
- Results publication: PubMed 36059540Puhlmann 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.
- 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 DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried Chicory Root in people with Inflammatory Bowel Diseases and Dietary Exposure, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in fecal calprotectin (time frame: difference between baseline and after 4-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016322, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.