- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018040
Vegetarian Diet in IBD (LOVIBD)
Efficacy of a Lacto-ovo Vegetarian Diet in Mild to Moderate IBD
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Charlene Grosse
- Phone Number: 0893826070
- Email: Cgrosse0@our.ecu.edu.au
Study Contact Backup
- Name: Claus Christophersen
- Phone Number: 0863045278
- Email: c.christophersen@ecu.edu.au
Study Locations
-
-
New South Wales
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Sydney, New South Wales, Australia
- Liverpool Hospital
-
-
Western Australia
-
Perth, Western Australia, Australia
- Royal Perth Hospital
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Perth, Western Australia, Australia, 6111
- St John of God Subiaco Hospital
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Perth, Western Australia, Australia
- Fiona Stanley Fremantle Hospitals Group
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Lacto-ovo vegetarian diet inclusive of dairy and eggs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with a clinical response at week 8
Time Frame: Week 8
|
A clinical response is defined as a decrease from baseline in the total Mayo score of at least three points, with an accompanying decrease in the subscore for rectal bleeding or at least 1 point or an absolute subscore for rectal bleeding of 0 or 1
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants achieving clinical remission at week 8
Time Frame: Week 8
|
A clinical remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point or a reduction in HBI of three points
|
Week 8
|
Number of participants with changes to IBDQ score at week 8
Time Frame: Week 8
|
Change in total score from baselines.
IBDQ - normal quality of life score is 170 points (range 32 to 224) and a quality of life response is a change of 16 points.
|
Week 8
|
Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8
Time Frame: Week 8
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Change in total score from baseline.
Lowest score of 29 reflects poor quality of life, maximum score of 145 reflects highest quality of life score.
|
Week 8
|
Participants SF-36 quality of life score at week 8
Time Frame: Week 8
|
SF-36- change in total score from baseline.
A score of 0 reflects maximum disability, the maximum score of 100 reflects no disability.
|
Week 8
|
Number of participants achieving a change in gut microbiome diversity at week 8
Time Frame: Week 8
|
The gut microbiome will be examined using ITS2, 16S rRNA gene and metagenomics.
|
Week 8
|
Number of participants with a change in beneficial gut metabolome profile at week 8
Time Frame: Week 8
|
Untargeted metabolomics will be performed on stool samples using high-resolution Gas Chromatography Mass Spectrometry (GC-Orbitrap-MS).
Metabolite identification will be established prior to statistical analysis, by matching against an in-house MS/MS spectral library of 900 metabolites and searching online spectral libraries (mzCloud, Metlin, HMDB and Massbank).
|
Week 8
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EdithCowanU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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