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

The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program for CD Control and Prevention

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: IBDMED; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lihi Godny, PhD; Phone Number: +97237525015; Email: lihigodny@gmail.com

Study Locations

• India
  • Hyderabad, India
    • Recruiting
    • Asian Institute Of Gastroenterology
    • Contact: Rupa Banerjee, Dr
• Israel
  • Petah Tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Lihi Godny, PhD; Phone Number: +97237525015; Email: lihigodny@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with early CD, defined as up to 12 months from diagnosis
2. 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)
3. 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.
4. Any stable concomitant CD therapy is allowed. 5-ASA (stable dose for at least 2 weeks), steroids (budesonide or any non topical corticosteroids)-stable dose for at least 2 weeks: prednisone up to 20 mg/day or budesonide up to 6 mg/day; immunomodulators (stable dose for 8 weeks) and/ or anti-TNFs at least 4 weeks after the end of induction or any optimization; anti integrins at least 4 weeks after the end of induction or any optimization; anti IL12/IL23 at least 4 weeks after the end of induction or any optimization; None of the above. For inclusion in a non-steroid group, a 2-week washout period will be required.
5. TB evaluation was done in the Indian population
6. For India-Hindi/Telugu speakers
7. Willing and able to sign an informed consent form
8. Willing and able to participate and adhere to IBDMED program

Exclusion Criteria:

1. Pregnant women
2. Diabetes mellitus
3. Any previous gastrointestinal surgery (except appendectomy)
4. Antibiotic therapy during the 4 weeks prior to enrollment. After enrollment, a non-CD short course of antibiotics will be allowed, if prescribed
5. 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)
6. Undernutrition or need for enteral nutrition supplementation according to the treating dietitian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IBDMED-ISR; Patients with newly diagnosed CD in Israel	Other: IBDMED; 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.; Other: Control; Dietary counseling according to the local dietary guidelines for patients with IBD
Other: IBDMED-IND; Patients with newly diagnosed CD in India	Other: IBDMED; 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.; Other: Control; Dietary counseling according to the local dietary guidelines for patients with IBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and inflammatory response	Decrease in inflammatory activity: at least 30% decrease in HBI and/or CDAI and the additional inflammatory biomarker used at inclusion. In any case where CRP or fecal calprotectin were elevated, they will be used to evaluate decreased activity.	8 weeks
Improvement in quality of life	Improved quality of life as assessed by the PRO2 (≥50% or ≥ 4 points)	8 weeks
Dietary adherance	Adherence to IBDMED in India and Israel-measured by IBDMED score. The IBDMED adherance screener includes 11 items and ranges between 0-30.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial outcomes- alpha diversity	Microbial diversity will be compared between groups and intra-individual changes will be assessed using paired analysis.	8 weeks
Microbial outcomes- Microbial dysbiosis index	MDI will be compared between groups and intra-individual changes will be assessed using paired analysis.	8 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: IBD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 0359-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No