Dried Chicory Root in IBD

Inflammatory Bowel Diseases Clinical Trial

— Chic-IBD  

Official title:

The Effect of Dried Chicory Root on Inflammation, Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06016322
• Other study ID #: NL85061.042.23
• Secondary ID: KIEM.K23.01.148
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: September 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Dietary Exposure
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Dietary Supplement:
• Dried Chicory Root
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).

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	MyMicroZoo, WholeFiber

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View Citation

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. Erratum In: Adv Nutr. 2021 Jul 30;12(4):1598. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Appreciation of WholeFiberTM evaluated by patients with CD and UC?	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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)	difference between baseline and after 4-week intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   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