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Vegetarian Diet in IBD (LOVIBD)

Primary Purpose

Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Lacto-ovo vegetarian diet

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Diet, Plant based diet, Lacto ovo vegetarian diet

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Liverpool Hospital
St John of God Subiaco HospitalRecruiting
Fiona Stanley Fremantle Hospitals GroupRecruiting
Royal Perth HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

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.

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).

Full Information

NCT ID

NCT04018040

First Posted

May 26, 2019

Last Updated

April 24, 2023

Sponsor

Edith Cowan University

Collaborators

St John of God Healthcare, Perth, Liverpool Hospital, South Western Sydney Local Health District, Fiona Stanley Fremantle Hospitals Group, Royal Perth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04018040

Brief Title

Vegetarian Diet in IBD

Acronym

LOVIBD

Official Title

Efficacy of a Lacto-ovo Vegetarian Diet in Mild to Moderate IBD

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 6, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Edith Cowan University

Collaborators

St John of God Healthcare, Perth, Liverpool Hospital, South Western Sydney Local Health District, Fiona Stanley Fremantle Hospitals Group, Royal Perth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases

Keywords

Diet, Plant based diet, Lacto ovo vegetarian diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Masking Description

Due to the nature of this type of dietary intervention it is not possible to blind the participant nor treating gastroenterolgist

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Lacto-ovo vegetarian diet

Intervention Description

Lacto-ovo vegetarian diet inclusive of dairy and eggs

Primary Outcome Measure Information:

Title

Number of participants with a clinical response at week 8

Description

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Number of participants achieving clinical remission at week 8

Description

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

Time Frame

Week 8

Title

Number of participants with changes to IBDQ score at week 8

Description

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.

Time Frame

Week 8

Title

Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8

Description

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.

Time Frame

Week 8

Title

Participants SF-36 quality of life score at week 8

Description

SF-36- change in total score from baseline. A score of 0 reflects maximum disability, the maximum score of 100 reflects no disability.

Time Frame

Week 8

Title

Number of participants achieving a change in gut microbiome diversity at week 8

Description

The gut microbiome will be examined using ITS2, 16S rRNA gene and metagenomics.

Time Frame

Week 8

Title

Number of participants with a change in beneficial gut metabolome profile at week 8

Description

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charlene Grosse

Phone

0893826070

Cgrosse0@our.ecu.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Claus Christophersen

Phone

0863045278

c.christophersen@ecu.edu.au

Facility Information:

Facility Name

Liverpool Hospital

City

Sydney

State/Province

New South Wales

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elie Saba

elie.saba@health.wa.gov.au

First Name & Middle Initial & Last Name & Degree

Susan Connor

Facility Name

St John of God Subiaco Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6111

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlene Grosse

Phone

0893826070

Cgrosse@our.ecu.edu.au

First Name & Middle Initial & Last Name & Degree

Ian Lawrance

First Name & Middle Initial & Last Name & Degree

Claus Christopherson

First Name & Middle Initial & Last Name & Degree

Amanda Devine

First Name & Middle Initial & Last Name & Degree

Johnny Lo

Facility Name

Fiona Stanley Fremantle Hospitals Group

City

Perth

State/Province

Western Australia

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Lightowler

Phone

61511154

daniel.lightowler@health.wa.gov.au

First Name & Middle Initial & Last Name & Degree

Charlene Grosse

Phone

893826070

Cgrosse0@our.ecu.edu.au

First Name & Middle Initial & Last Name & Degree

Lena Thin

Facility Name

Royal Perth Hospital

City

Perth

State/Province

Western Australia

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherman Picardo

First Name & Middle Initial & Last Name & Degree

Charlene Grosse

Phone

8093826070

Cgrosse0@our.ecu.edu.au

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

All data will be de-identified

Learn more about this trial

Vegetarian Diet in IBD

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