The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program

NCT05536544 | Unknown

• 1 other identifier: 0359-21
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

The rising incidence of Crohn's disease (CD) and ulcerative colitis (UC), especially in the newly industrialized nations of Asia, highlights the possible role of environmental triggers such as diet and the gut microbiome in the pathogenesis of inflammatory bowel diseases (IBD). The Mediterranean diet (MED) has been previously correlated with beneficial outcomes in several chronic and immune-mediated diseases and has been linked with positive outcomes in IBD. However, consumption of high fiber foods like fruits, vegetables, whole grains, legumes and nuts may be challenging for patients with IBD without tight dietary guidance and support. The IBDMED nutritional education program aims to improve the adherence of patients with IBD to MED. Patients are educated on how to implement and incorporate MED principles into their daily lifestyle, by providing information, tips, practical tools, cooking methods and recipes, that are available on an interactive website and application. Patients are monitored for their diet, sleep, physical activity and stress levels via fitness trackers and questionnaires developed for this study and receive feedback and personal recommendations from the study dietitians along the way. This RCT will assess the feasibility and effects of an 8-week IBDMED nutritional and lifestyle education program vs. the nutritional standard of care in patients with newly diagnosed CD and in healthy subjects in Israel and India.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD

Outcome Measures

Primary Outcomes (1)

• Composite biological score

  A composite biological score comprised of changes in clinical (HBI/CDAI), inflammatory (CRP/calprotectin) and microbial (diversity, MDI) indices. A decrease in clinical indices, inflammatory markers or MDI will be considered positive and will be scored as follows: -10%: +1 point, -20%: +2 points, -30%: +3 points; An increase in microbial diversity will be considered positive and will be scored as follows: +10%: +1 point, +20%: +2 points, +30%: +3 points. The composite biological score ranges between 0-15 points.

  8 weeks

Secondary Outcomes (3)

• Clinical and inflammatory response

  8 weeks

• Improvement in quality of life

  8 weeks

• Dietary adherance

  8 weeks

Other Outcomes (2)

• Microbial outcomes- alpha diversity

  8 weeks

• Microbial outcomes- Microbial dysbiosis index

  8 weeks

Study Arms (2)

IBDMED-ISR

OTHER

Patients with newly diagnosed CD in Israel

Other: IBDMED; Other: Control

IBDMED-IND

OTHER

Patients with newly diagnosed CD in India

Other: IBDMED; Other: Control

Interventions

IBDMED OTHER

The IBDMED program will be applied for 8 weeks and include education on MED diet and lifestyle components, focused on increasing and diversifying dietary fiber intake, reduction of ultra-processed food intake and promoting an active lifestyle. This intervention is digitally supported by an interactive website application and step trackers to monitor lifestyle parameters.

IBDMED-IND; IBDMED-ISR

Control OTHER

Dietary counseling according to the local dietary guidelines for patients with IBD

IBDMED-IND; IBDMED-ISR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with early CD, defined as up to 12 months from diagnosis
• Inflammatory (B1) phenotype, specifically-no known fibrostenotic (B2) or internal penetrating (B3) disease. No known perianal disease (p). Any CD location will be included (L1-4)
• Patients with mild CD as measured by HBI 5-7 or CDAI 150-220 or patients with HBI\<5 or CDAI\<150 with at least one additional objective measure of inflammation: 1. inflammatory biomarkers: elevated CRP or fecal calprotectin at enrollment; active disease by endoscopy or VCE performed up to 12 weeks prior to enrollment; active inflammation demonstrated by imaging (CTE, MRE, IUS) performed up to 12 weeks prior to enrollment.
• TB evaluation was done in the Indian population
• For India-Hindi/Telugu speakers
• Willing and able to sign an informed consent form
• Willing and able to participate and adhere to IBDMED program

You may not qualify if:

• Pregnant women
• Diabetes mellitus
• Any previous gastrointestinal surgery (except appendectomy)
• Antibiotic therapy during the 4 weeks prior to enrollment. After enrollment, a non-CD short course of antibiotics will be allowed, if prescribed
• Any concomitant disease or treatment that according to the treating physician considerations interferes with patient safety or study outcomes (specifically-uncontrolled thyroid disease, renal failure)
• Undernutrition or need for enteral nutrition supplementation according to the treating dietitian

Sponsors & Collaborators

• Rabin Medical Center: lead
• Asian Institute of Gastroenterology: collaborator

Study Sites (2)

Asian Institute of Gastroenterology

Hyderabad, India

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Iris Dotan, Prof

CONTACT

+97237525015; irisdo@clalit.org.il

Lihi Godny, PhD

CONTACT

+97237525015; lihigodny@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of The Gastroenterology Division

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

IN (1); IL (1)