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

Primary Purpose

Inflammatory Bowel Diseases

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

IBDMED

Control

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases focused on measuring IBD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.
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.
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

Exclusion Criteria:

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

Sites / Locations

Asian Institute of GastroenterologyRecruiting
Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

IBDMED-ISR

IBDMED-IND

Arm Description

Patients with newly diagnosed CD in Israel

Patients with newly diagnosed CD in India

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Improvement in quality of life

Improved quality of life as assessed by the PRO2 (≥50% or ≥ 4 points)

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.

Full Information

NCT ID

NCT05536544

First Posted

September 1, 2022

Last Updated

September 8, 2022

Sponsor

Rabin Medical Center

Collaborators

Asian Institute of Gastroenterology

1. Study Identification

Unique Protocol Identification Number

NCT05536544

Brief Title

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

Acronym

IBDMED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

Collaborators

Asian Institute of Gastroenterology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

Keywords

IBD

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IBDMED-ISR

Arm Type

Other

Arm Description

Patients with newly diagnosed CD in Israel

Arm Title

IBDMED-IND

Arm Type

Other

Arm Description

Patients with newly diagnosed CD in India

Intervention Type

Other

Intervention Name(s)

IBDMED

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Composite biological score

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Clinical and inflammatory response

Description

Time Frame

8 weeks

Title

Improvement in quality of life

Description

Improved quality of life as assessed by the PRO2 (≥50% or ≥ 4 points)

Time Frame

8 weeks

Title

Dietary adherance

Description

Adherence to IBDMED in India and Israel-measured by IBDMED score. The IBDMED adherance screener includes 11 items and ranges between 0-30.

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Microbial outcomes- alpha diversity

Description

Microbial diversity will be compared between groups and intra-individual changes will be assessed using paired analysis.

Time Frame

8 weeks

Title

Microbial outcomes- Microbial dysbiosis index

Description

MDI will be compared between groups and intra-individual changes will be assessed using paired analysis.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Iris Dotan, Prof

Phone

+97237525015

irisdo@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Lihi Godny, PhD

Phone

+97237525015

lihigodny@gmail.com

Facility Information:

Facility Name

Asian Institute of Gastroenterology

City

Hyderabad

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupa Banerjee, Dr

Facility Name

Rabin Medical Center

City

Petah Tikva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Iris Dotan, Prof

Phone

+97237525015

irisdo@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Lihi Godny, PhD

Phone

+97237525015

lihigodny@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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