Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission

NCT04835727 | Completed DMC

• 1 other identifier: Si 063/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In the 21st century, the incidence of inflammatory bowel disease (IBD) globally increases. Higher incidence of IBD development may implicate that environmental factors played essential roles in IBD pathogenesis. One of the environmental factors is a westernized diet that contains a high amount of animal protein and a low amount of dietary fiber. This kind of diet can lead to gut microbial dysbiosis and increase susceptibility to IBD. A microbial dysbiosis pattern in IBD is a decrease in microbial diversity and the inversed ratio of local protective and pathologic bacteria. High animal protein was associated with an increased risk of IBD and increased risk of disease relapse meanwhile dietary fiber was associated with IBD risk reduction. A semi-vegetarian diet is a diet with high fiber and low red meat and processed food that may reduce inflammatory activity in IBD. The study in the semi-vegetarian diet in IBD activity is still limited. This study aimed to evaluate a semi-vegetarian diet's effect in maintaining IBD remission in disease quiescence patients.

Conditions

Inflammatory Bowel Diseases; Calprotectin; Fecal Microbiota; Vegetarian Diet

Keywords

Vegetarian diet; inflammatory bowel diseases

Outcome Measures

Primary Outcomes (1)

• Rate of participants with clinical relapses

  Effect of semi-vegetarian food consumption on the rate of participants with clinical relapses assessed by Crohn's disease activity index for Crohn's disease and the clinical Mayo Score or partial Mayo Score for ulcerative colitis. The Crohn's disease activity index ranges from 0 to 1100, a higher score means a worse outcome, and clinical relapse is defined if the score is at least 150 points. The clinical Mayo Score for ulcerative colitis ranges from 0 to 9, a higher score means a worse outcome, and clinical relapse is defined if the score is at least 2 points.

  1 year

Secondary Outcomes (5)

• C-Reactive Protein (CRP)

  1 year

• fecal calprotectin level

  1 year

• Fecal microbiota

  1 year

• Quality of life score of SIBDQ

  1 year

• Quality of life score of EQ5D3L

  1 year

Study Arms (1)

Semi-vegetarian diet

EXPERIMENTAL

All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food.

Other: Semi-vegetarian diet and increase fiber consumption

Interventions

Semi-vegetarian diet and increase fiber consumption OTHER

All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food.

Semi-vegetarian diet

Eligibility Criteria

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

You may qualify if:

• Patients with Crohn's disease or Ulcerative colitis
• Age ≥ 18 years old
• Disease in remission at least 2weeks by following criteria Crohn's disease: Crohn's Disease Activity Index(CDAI) \< 150 Ulcerative colitis: Mayo Ulcerative Colitis Subscore ≤ 2
• Prednisolone ≤ 15 mg/day for at least 1 month
• Stable immunomodulator dosage at least 1 month
• Stable biologic agent at least 2 months

You may not qualify if:

• Patients with Ulcerative colitis with a history of proctocolectomy
• Patients with Crohn's disease with bowel stricture
• Patients with recently antibiotic usage within 1 month
• Pregnant patients

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective interventional cohort study in patients with clinically quiescent IBD. At enrollment, clinical information, dietary intake, inflammatory markers, and fecal microbiota were recorded. Dietary intake was assessed by an experienced nutritionist using pictures of food, a dietary questionnaire, and patient interviewing. The nutritionist advised the participants to intake a semi-vegetarian diet and increase dietary fiber consumption. The changes in clinical symptoms, dietary intake, inflammatory markers, and fecal microbiota were recorded in each visit for 1 year.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: January 21, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

TH (1)