Status:
COMPLETED
Vegetarian Diet in IBD
Lead Sponsor:
Edith Cowan University
Collaborating Sponsors:
St John of God Healthcare, Perth
Fiona Stanley Fremantle Hospitals Group
Conditions:
Ulcerative Colitis
Crohn Disease
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
To determine whether a lacto-ovo vegetarian diet is effective in improving gastrointestinal symptoms, quality-of-life, intestinal inflammation and gut microbiota composition in mild-to-moderate IBD co...
Detailed Description
This study will review whether a lacto-ovo vegetarian diet is an optimal dietary therapy to achieve a clinical response in mild to moderate UC and CD as an adjunctive treatment to current medical ther...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04018040
Start Date
May 6 2019
End Date
August 10 2023
Last Update
February 20 2024
Active Locations (4)
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1
Liverpool Hospital
Sydney, New South Wales, Australia
2
St John of God Subiaco Hospital
Perth, Western Australia, Australia, 6111
3
Fiona Stanley Fremantle Hospitals Group
Perth, Western Australia, Australia
4
Royal Perth Hospital
Perth, Western Australia, Australia