Impact of Vitamins and Anti-Inflammatory Diet on Crohn's Disease

Potential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID Study

This study is testing if a special anti-inflammatory diet and certain vitamins can help people with Crohn's disease feel better and improve their gut health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 510 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University Medical Center Groningen (other)
• Drugs / interventions: Methotrexate
• Locations: 1 site (Groningen)
• Trial ID: NCT04913467 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of the Groningen Anti-Inflammatory Diet and the delivery of vitamins B2, B3, and C on patients with Crohn's disease and healthy volunteers. It aims to determine if these interventions can positively influence the disease course and alter the gut microbiome. The study recognizes the importance of diet and microbiome in inflammatory bowel diseases and seeks to provide evidence-based dietary guidelines for patients. Participants will be monitored for adherence to the diet and the effects on their health outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with Crohn's disease who have low to mild disease activity and are willing to follow a dietary intervention.

Not a fit: Patients with severe disease activity or those who have not been diagnosed with Crohn's disease or any chronic inflammatory condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a dietary approach that improves the management of Crohn's disease and enhances patients' quality of life.

How similar studies have performed: Other studies have shown promising results with dietary interventions in Crohn's disease, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria CD patients:

* 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)

Inclusion Criteria healthy volunteers:

* 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)

Exclusion Criteria CD patients:

* 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

Exclusion Criteria healthy subjects:

* Life expectancy \<12 months
* Previously diagnosed with IBD or any other chronic inflammatory condition
* 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)
* With a history of GI disorders or taken drugs that are likely to interfere with mode of action of interventions, such as chronic use of antacids or proton-pump inhibitors
* Abnormal clinical chemistry and haematology laboratory test results of clinical significance that in the judgment of the investigator would interfere with the participant's ability to comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
* Presence of a stoma
* History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
* Recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>60g (men) / 40g (women) pure alcohol per day (1.5 l / 1 l beer resp. 0.75 l / 0.5 l wine).
* Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period) The method of contraception must be recorded in the source documentation.
* 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

Where this trial is running

Groningen

• University Medical Center Groningen — Groningen, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Gerard Dijkstra, MD PhD

Conditions: Crohn Disease, Inflammatory Bowel Disease, IBD, Crohn, Vitamins, Diet, Riboflavin, Ascorbic Acid