Vegetarian Diet in IBD

NCT04018040 | Completed

• 1 other identifier: EdithCowanU
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

Ulcerative Colitis; Crohn Disease; Inflammatory Bowel Diseases

Keywords

Diet; Plant based diet; Lacto ovo vegetarian diet

Outcome Measures

Primary Outcomes (1)

• 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

  Week 8

Secondary Outcomes (6)

• Number of participants achieving clinical remission at week 8

  Week 8

• Number of participants with changes to IBDQ score at week 8

  Week 8

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

  Week 8

• Participants SF-36 quality of life score at week 8

  Week 8

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

  Week 8

Study Arms (1)

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.

Other: Lacto-ovo vegetarian diet

Interventions

Lacto-ovo vegetarian diet OTHER

Lacto-ovo vegetarian diet inclusive of dairy and eggs

Intervention Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Edith Cowan University: lead
• St John of God Healthcare, Perth: collaborator
• Fiona Stanley Fremantle Hospitals Group: collaborator
• Royal Perth Hospital: collaborator

Study Sites (4)

Liverpool Hospital

Sydney, New South Wales, Australia

Location

St John of God Subiaco Hospital

Perth, Western Australia, 6111, Australia

Location

Fiona Stanley Fremantle Hospitals Group

Perth, Western Australia, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Interventions

Diet, Vegetarian

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the nature of this type of dietary intervention it is not possible to blind the participant nor treating gastroenterolgist
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Accredited Practising Dietitian, PhD Candidate

Model Details: 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)

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: July 12, 2019
• Study Start: May 6, 2019
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)