Vegetarian Diet in IBD (LOVIBD)
Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Diet, Plant based diet, Lacto ovo vegetarian diet
Eligibility Criteria
Inclusion Criteria I. Is able to provide informed consent. II. Is over the age of 18 years. III. Has a diagnosis of ulcerative colitis or Crohn's disease for over a 3-month duration that was confirmed by a specialist gastroenterologist IV. Pro-6 score of 2 to 4, partial mayo 3-6 (mild to moderate UC) or Harvey Bradshaw Index (HBI) 5 to 15 (Crohn's disease)
V. Medications:
- Oral 5-Aminosalicylates: If taking an oral 5-Aminosalicylates the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
- Oral Corticosteroids: If taking oral corticosteroids the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit at a dose of ≤30mg.
- Oral Azathioprine/6MP, Methotrexate or tacrolimus: If taking one of these medications the patient has used them for a minimum of 12 weeks and has been on a stable dose for 4 weeks prior to screening.
- Biologic therapy with infliximab, adalimumab or vedolizumab: If taking one of these medications the patient has used them for a minimum of 12 weeks
- Rectal Preparations; 5-Aminosalicylates, corticosteroids or tacrolimus: If taking one of these medications the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
VI. Willing to participate in the study and comply with the proceedings by signing a written informed consent.
VII. Free of any clinically significant disease, other than ulcerative colitis/Crohn's disease, that would interfere with the study's evaluations.
VIII. Subjects can read and understand English and is able to adhere to the study methodology and visit schedules.
Exclusion Criteria
I. Has been on antibiotics within the last four weeks. II. Has a known food allergy to nuts, soy, eggs or dairy. III. Is pregnant or breast feeding. IV. Following a vegetarian, vegan or low FODMAP diet. V. Has known dementia and the inability to understand the trial requirements. VI. Ulcerative colitis: Patients with less than 15cm of disease (proctitis) VII. Crohn's disease: Patients with severe Disease (HBI > 15) or remission (HBI<5) VIII. Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease (Boneh et al, 2017)
Sites / Locations
- Liverpool Hospital
- St John of God Subiaco HospitalRecruiting
- Fiona Stanley Fremantle Hospitals GroupRecruiting
- Royal Perth HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Intervention Group
Patients will follow a lacto-ovo vegetarian diet for an 8 week period. patients will be provided with a lacto-ovo vegetarian food box delivery service with fresh ingredients and recipes to cover four dinners per week.