Dried Chicory Root in IBD

NCT06016322 | Unknown DMC

• 2 other identifiers: NL85061.042.23KIEM.K23.01.148
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Dietary Exposure

Keywords

Inflammatory bowel disease; dietary fiber; gut microbiome; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (36)

• Change in IBD complaints by HBI for CD

  difference between baseline and after 4-week intervention

• Change in IBD complaints by SCCAI for UC

  difference between baseline and after 4-week intervention

• Change in QOL measured by IBDQ

  difference between baseline and after 4-week intervention

• Change in the Food-related Quality of Life (FrQOL)

  difference between baseline and after 4-week intervention

• Change in stool consistency

  difference between baseline and after 4-week intervention

Other Outcomes (4)

• Difference in change in fecal calprotectin between patients with CD and UC

  difference between baseline and after 4-week intervention

• Appreciation of WholeFiberTM evaluated by patients with CD and UC?

  after 4-week intervention

• The convenience of the use of WholeFiberTM evaluated by patients with CD and UC?

  after 4-week intervention

Study Arms (1)

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.

Dietary Supplement: Dried Chicory Root

Interventions

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).

Also known as: WholeFiber Trademark (TM)

Before and after study in 6 patients with UC and 6 patients wiht CD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• WholeFiber: collaborator
• MyMicroZoo: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 32199025 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.

  PMID: 34486663 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.

  PMID: 36059540 RESULT

Related 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

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Inflammation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 29, 2023
• Study Start: October 2, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)