Vegetarian Diet in IBD
- Conditions
- Ulcerative ColitisCrohn DiseaseInflammatory Bowel Diseases
- Interventions
- Other: Lacto-ovo vegetarian diet
- Registration Number
- NCT04018040
- Lead Sponsor
- Edith Cowan University
- 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 compared to a standard omnivorous diet.
- 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 therapies. The proposed studyT will be used to evaluate the efficacy of a lacto-ovo vegetarian diet together with its effect on the microbiota to create an enhanced understanding of the role diet plays in the management midl to moderate IBD. Using a socially acceptable diet it is anticipated that food-related quality-of-life measures will improve for participants. Dietary modification could be a more economical, safer and more effective means of reducing symptoms and flare-ups compared to pharmacological therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group Lacto-ovo vegetarian diet 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.
- Primary Outcome Measures
Name Time Method Number of participants with a clinical response at week 8 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
- Secondary Outcome Measures
Name Time Method Number of participants achieving clinical remission at week 8 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
Number of participants with changes to IBDQ score at week 8 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.
Number of participants achieving a change in gut microbiome diversity at week 8 Week 8 The gut microbiome will be examined using ITS2, 16S rRNA gene and metagenomics.
Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8 Week 8 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.
Participants SF-36 quality of life score at week 8 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.
Number of participants with a change in beneficial gut metabolome profile at week 8 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).
Trial Locations
- Locations (4)
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Fiona Stanley Fremantle Hospitals Group
🇦🇺Perth, Western Australia, Australia
St John of God Subiaco Hospital
🇦🇺Perth, Western Australia, Australia