Ulcerative ColitisLOVIBDNCT04018040
Vegetarian Diet in IBD
A study testing Lacto-ovo vegetarian diet in people with Ulcerative Colitis and Crohn Disease, run by Edith Cowan University at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- Lacto-ovo vegetarian diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesAustralia
- Study dates
- 6 May 2019to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
St John of God Subiaco Hospital
Perth, Western Australia, 6111
Fiona Stanley Fremantle Hospitals Group
Perth, Western Australia
Royal Perth Hospital
Perth, Western Australia
Liverpool Hospital
Sydney, New South Wales
About this study
Official title: Efficacy of a Lacto-ovo Vegetarian Diet in Mild to Moderate IBD
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.
Read the 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.
- Being tested
- Lacto-ovo vegetarian diet
- Keywords
- Diet, Plant based diet, Lacto ovo vegetarian diet
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacto-ovo vegetarian dietOther
Lacto-ovo vegetarian diet inclusive of dairy and eggs
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Lacto-ovo vegetarian diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a clinical response at 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
Measured: Week 8
Secondary outcomes (6)
Number of participants achieving clinical remission at 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
Measured: Week 8
Number of participants with changes to IBDQ score at 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.
Measured: Week 8
Participants Food related quality of life in IBD (Fr-QoL 29) score at 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.
Measured: Week 8
Participants SF-36 quality of life score at 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.
Measured: Week 8
Number of participants achieving a change in gut microbiome diversity at week 8
The gut microbiome will be examined using ITS2, 16S rRNA gene and metagenomics.
Measured: Week 8
Number of participants with a change in beneficial gut metabolome profile at 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).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start6 May 2019
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1: Open labelled, single centre trial in mild to moderate UC ( n=14) Phase 2:Open labelled, single centre trial in mild to moderate CD (n-12)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edith Cowan University
- Sponsor type
- University, hospital or other
- Collaborators
- St John of God Healthcare, Perth, Fiona Stanley Fremantle Hospitals Group, Royal Perth Hospital
- Responsible party
- Principal investigator, Charlene Grosse, Edith Cowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018040
- Sponsor's protocol ID
- EdithCowanU
- Acronym
- LOVIBD
- Status last verified
- Feb 2024
- First submitted
- 26 May 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Lacto-ovo Vegetarian Diet in Mild to Moderate IBD
- ClinicalTrials.gov ID
- NCT04018040
- Acronym / sponsor ID
- LOVIBD / EdithCowanU
- Keywords
- Diet, Plant based diet, Lacto ovo vegetarian diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Edith Cowan UniversityUniversity, hospital or other
- Collaborators
- St John of God Healthcare, Perth, Fiona Stanley Fremantle Hospitals Group, Royal Perth Hospital
- Study start
- 6 May 2019 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: Open labelled, single centre trial in mild to moderate UC ( n=14) Phase 2:Open labelled, single centre trial in mild to moderate CD (n-12)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Lacto-ovo vegetarian dietPatients 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacto-ovo vegetarian dietLacto-ovo vegetarian diet inclusive of dairy and eggs | Other | Intervention Group |
Primary outcome
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
6 secondary outcomes
Number of participants achieving clinical remission at week 8
Time frame: Week 8
Number of participants with changes to IBDQ score at week 8
Time frame: Week 8
Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8
Time frame: Week 8
Participants SF-36 quality of life score at week 8
Time frame: Week 8
Number of participants achieving a change in gut microbiome diversity at week 8
Time frame: Week 8
Number of participants with a change in beneficial gut metabolome profile at week 8
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No. All data will be de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacto-ovo vegetarian diet in people with Ulcerative Colitis and Crohn Disease, run by Edith Cowan University at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a clinical response at week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.