Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers

NCT04913467 | Unknown

• 2 other identifiers: NL66008.056.20202000683
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Disease; IBD; Crohn; Vitamins; Diet; Riboflavin; Ascorbic Acid; Niacin; Microbiome

Outcome Measures

Primary Outcomes (2)

• Change in faecal calprotectin

  Primary outcome for CD patients

  Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months

• Change in microbiome composition measured by metagenomic sequencing- based profiles

  Primary outcome for healthy volunteers and CD patients

  Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months

Secondary Outcomes (4)

• The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)

  Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months

• Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)

  Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months

• Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)

  Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months

• Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire

  Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months

Study Arms (3)

Groningen Anti-Inflammatory Diet (GrAID)

EXPERIMENTAL

Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups.

Other: Groningen Anti-Inflammatory Diet (GrAID)

ColoVit capsule

EXPERIMENTAL

2 times daily intake of a supplement containing 37,5 mg vitamin B2, 2,5 mg vitamin B3 and 250 mg vitamin C in a ColoPulse-coated capsule, a pH-sensitive coating allowing ileocolonic-targeted-delivery

Dietary Supplement: ColoVit capsule

Placebo capsule

PLACEBO COMPARATOR

2 times daily intake of a capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit

Other: ColoPulse-placebo capsule

Interventions

Groningen Anti-Inflammatory Diet (GrAID) OTHER

Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Basically, subjects will be instructed to increase uptake of food components that hold potential anti-inflammatory proportions and to avoid food components that may showcase potential pro-inflammatory proportions.

Groningen Anti-Inflammatory Diet (GrAID)

ColoVit capsule DIETARY_SUPPLEMENT

Vitamin B2/B3/C supplement in a ColoPulse-coated capsule

ColoVit capsule

ColoPulse-placebo capsule OTHER

A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant understands the study procedures and signed an informed consent to participate in this study
• Previously diagnosed with CD; Montreal classification: L1 (Ileal), L2 (colonic), or L3 (ileocolonic).
• Low-mild disease activity (no clinically relevant symptoms and HBI\<8 or CDAI \<220)
• Evidence of mucosal inflammation (faecal calprotectin ≥100 μg/g)
• Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala
• ≥18 years of age
• Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)
• Participant understands the study procedures and signed an informed consent to participate in this study
• Never been diagnosed with IBD or any other chronic inflammatory condition.
• Participant has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
• Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala
• ≥18 year of age
• Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)

You may not qualify if:

• Life expectancy \<12 months
• Active Crohn's disease (HBI≥8 or CDAI\>220), or expecting drug intervention within 3 months
• Colonoscopy and colon cleansing in the past 3 months;
• Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention
• Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium)
• Use Methotrexate drugs or chronic use of antacids, H2 or proton-pump inhibitors
• With a history of GI disorders or GI surgery that are likely to interfere with the pH-dependent mode of action of the Colovit-capsule
• Patients with a pouch or stoma
• Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period)
• Swallowing disorders, not able to tolerate oral food, or use of tube feeding (EEN)
• Previously proven anaphylactic reaction to foods included in the food boxes
• Previously diagnosed with Celiac Disease or following a gluten-free diet
• Following a vegetarian or vegan diet
• Life expectancy \<12 months
• Previously diagnosed with IBD or any other chronic inflammatory condition

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Related Publications (1)

• Otten AT, Peters V, Barth I, Stevens CL, Bourgonje AR, Frijlink HW, Harmsen HJM, Rehman A, Campmans-Kuijpers MJE, Dijkstra G. Effects of ileocolonic delivered vitamin B2, B3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn's disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial. BMJ Open. 2023 Mar 14;13(3):e069654. doi: 10.1136/bmjopen-2022-069654.

  PMID: 36918234 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Gerard Dijkstra, MD PhD

CONTACT

+31 050 3612620; gerard.dijkstra@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Inflammatory Bowel Disease Center and Intestinal Transplantation Center

Model Details: Randomized, partly blinded, multicenter clinical food trial

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: June 4, 2021
• Study Start: October 8, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)