Vegetarian Diet in Ulcerative Colitis (LOVUC)
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|ClinicalTrials.gov Identifier: NCT04018040|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Lacto-ovo vegetarian diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase 1: Open labelled, single centre trial (10 patients) Phase 2: Open labelled, single centre, single blinded, randomised controlled clinical trial (n=30).|
|Masking:||Single (Care Provider)|
|Masking Description:||Due to the nature of this type of dietary intervention it is not possible to blind the participant, but the assessing doctor will be blinded to the patient's diet during phase two.|
|Official Title:||Efficacy of a Lacto-ovo Vegetarian Diet in Ulcerative Colitis: a Randomised Controlled Trial|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||November 2022|
No Intervention: Control Group
Patients will be asked to continue their usual diet patterns over an 8 week period
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.
Other: Lacto-ovo vegetarian diet
Lacto-ovo vegetarian diet inclusive of dairy and eggs
- 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
- 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.
- 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.
- Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8 [ Time Frame: 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 [ 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.
- Number of participants achieving mucosal healing at week 8 [ Time Frame: Week 8 ]Mucosal healing is defined as an absolute endoscopy subscore of 0 or 1(maximum score of 3).
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018040
|Contact: Charlene Grosse||0893826070||Cgrosse0@our.ecu.edu.au|
|Contact: Claus Christophersenfirstname.lastname@example.org|
|Australia, Western Australia|
|St John of God Subiaco Hospital||Recruiting|
|Perth, Western Australia, Australia, 6111|
|Contact: Charlene Grosse 0893826070 Cgrosse@our.ecu.edu.au|
|Sub-Investigator: Ian Lawrance|
|Sub-Investigator: Claus Christopherson|
|Sub-Investigator: Amanda Devine|
|Sub-Investigator: Johnny Lo|