Vegetarian Diet in IBD

NCT ID: NCT04018040

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2023-08-10

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.

Conditions

Ulcerative Colitis; Crohn Disease; Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lacto-ovo vegetarian diet

Intervention Type: OTHER

Lacto-ovo vegetarian diet inclusive of dairy and eggs

Interventions

Lacto-ovo vegetarian diet

Lacto-ovo vegetarian diet inclusive of dairy and eggs

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

V. Medications:

1. 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.

2. 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.

3. 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.

4. Biologic therapy with infliximab, adalimumab or vedolizumab: If taking one of these medications the patient has used them for a minimum of 12 weeks

5. 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St John of God Healthcare, Perth

UNKNOWN

Sponsor Role: collaborator

Fiona Stanley Fremantle Hospitals Group

UNKNOWN

Sponsor Role: collaborator

Royal Perth Hospital

OTHER

Sponsor Role: collaborator

Edith Cowan University

OTHER

Sponsor Role: lead

Responsible Party

Charlene Grosse

Advanced Accredited Practising Dietitian, PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Liverpool Hospital

Sydney, New South Wales, Australia

St John of God Subiaco Hospital

Perth, Western Australia, Australia

Fiona Stanley Fremantle Hospitals Group

Perth, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

EdithCowanU

Identifier Type: -

Identifier Source: org_study_id