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Dietary Intervention for Inflammatory Bowel Disease Remission

Primary Purpose

Inflammatory Bowel Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mediterranean diet and Anti-inflammatory diet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • Diagnosis of IBD (according to clinical, endoscopic and histological criteria). Receiving pharmacotherapy for IBD. Exclusion Criteria: Pediatric patients (less than 18 years old) Pregnant or breastfeeding patients Patients with concomitant alimentary tract disorders, such as malabsorption and celiac disease Patients requiring specific dietary interventions, such as diabetes mellitus, heart failure, renal failure, nephrosis, and liver failure, and neoplastic disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Mediterranean diet group

    Anti-inflammatory diet group

    control group

    Arm Description

    following dietary intervention based on Mediterranean diet

    following dietary intervention based on IBD-Anti-inflammatory diet.

    Patients of the control group will not be instructed to follow a specific dietary intervention.

    Outcomes

    Primary Outcome Measures

    Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
    by standard biochemical procedures, such as C-reactive protein (CRP).
    Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
    standard biochemical procedures, such as C-reactive protein (CRP) and fecal calprotectin (FC) levels.
    Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
    For UC patients, Clinician based Simple Clinical Colitis Activity Index (SCCAI) categorize two types of patients: patients with inactive disease (SCCAI score < 5) and patients with active disease (SCCAI score ≥ 5).
    Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
    by using Mayo score/disease activity index (Mayo/DAI) A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.
    Induction of disease remission (CD) by adding adjunct dietary interventions combined with pharmacotherapy.
    . For Crohn's disease patients, Modified Harvey Bradshaw Index will be used with score ≤ 5 indicate remission, =5-7mild disease ,8-16 moderate disease, ≥ 16 in severe disease.

    Secondary Outcome Measures

    Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
    will be at two points of time: after four weeks and after 12 weeks by using Mediterranean Diet Serving Score (MDSS) (16) for MD adherence.
    Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
    will be at two points of time: after four weeks and after 12 weeks by using Anti- Inflammatory Diet Serving Score for IBD- AID adherence. The AID Serving Score (AIDSS) is based on the latest update of the Anti-Inflammatory Diet Pyramid, using the recommended consumption frequency of foods and food group.

    Full Information

    First Posted
    March 18, 2023
    Last Updated
    June 18, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05920187
    Brief Title
    Dietary Intervention for Inflammatory Bowel Disease Remission
    Official Title
    Additive Modified Mediterranean Dietary Intervention Versus Modified Anti-inflammatory Dietary Intervention for Inflammatory Bowel Disease Remission
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2025 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To compare adding dietary intervention based on MD to dietary intervention based on IBD-AID on induction of disease remission of IBD patients receiving pharmacotherapy. To compare patients' adherence to dietary intervention based on MD to dietary intervention based on IBD-AID, and the impact of adherence on induction of remission among patients with IBD receiving pharmacotherapy.
    Detailed Description
    Inflammatory bowel disease (IBD) is a chronic inflammatory disorder with two major types; ulcerative colitis (UC) and Crohn's disease (CD) . There is a growing incidence of IBD in the Arab world, with incidence rate of 2.33 per 100,000 persons per year for UC and 1.46 per 100,000 persons per year for CD. Due to this increasing incidence, it is likely that IBD will become a major health problem in the future. Pathogenesis of IBD is not fully understood yet, recent studies suggest that IBD is associated with a multifactorial process involving genetics, environmental factors, microbiota, and deregulation of the immune system. Diet is one of the environmental factors involved in the onset and course of IBD. Accumulating evidence points to gut dysbiosis combined with aberrant immune response in genetically predisposed individuals; a process probably triggered and maintained by changes in environmental factors, including diet ; the exact interplay between these factors is still unknown. Since the prevalence of IBD is highest in the Western world, affecting up to 0.5% of the general population in 2015, it is thought that the Western diet, high in fats and sugars and low in vegetables and fruits, contributes to the development of IBD. Several diets have been proposed for the treatment or prevention of different diseases. One of the most widely used is the Mediterranean diet (MD), which was recently suggested for management of several diseases. The traditional Mediterranean diet is characterized by high consumption of vegetables, fruits, olive oil, nuts, and legumes, as well as fish and unprocessed cereals, low intake of meat, meat products, and dairy products . Another diet, the IBD anti-inflammatory diet (AID) which restricts intake of certain carbohydrates and includes pre- and probiotic foods and modified dietary fatty acids showed some improvements in a case series study as adjunct dietary therapy for treatment of IBD patient. Application of healthier dietary patterns has been considered effective, non-invasive, and long-lasting therapy. Therapeutic diets should be evaluated as an adjunct therapy to reduce number and/or dose of IBD medications, with consequent reduction of cost and adverse effects. However, high-quality data to guide the dietary recommendations are still lacking.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mediterranean diet group
    Arm Type
    Active Comparator
    Arm Description
    following dietary intervention based on Mediterranean diet
    Arm Title
    Anti-inflammatory diet group
    Arm Type
    Active Comparator
    Arm Description
    following dietary intervention based on IBD-Anti-inflammatory diet.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Patients of the control group will not be instructed to follow a specific dietary intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Mediterranean diet and Anti-inflammatory diet
    Other Intervention Name(s)
    MD and AID
    Intervention Description
    Cases will be randomly allocated to two groups: Mediterranean diet group (following dietary intervention based on MD), and Anti_inflammatory diet group(following dietary intervention based on IBD-AIF). Patients of the control group will not be instructed to follow a specific dietary intervention. Evaluation of adherence of cases to dietary intervention will be at two points of time: after four weeks and after 12 weeks by using Mediterranean Diet Serving Score (MDSS) for MD adherence and Anti- Inflammatory Diet Serving Score for IBD- AID adherence. The AID Serving Score (AIDSS) is based on the latest update of the Anti-Inflammatory Diet Pyramid, using the recommended consumption frequency of foods and food group.
    Primary Outcome Measure Information:
    Title
    Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
    Description
    by standard biochemical procedures, such as C-reactive protein (CRP).
    Time Frame
    12 weeks
    Title
    Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
    Description
    standard biochemical procedures, such as C-reactive protein (CRP) and fecal calprotectin (FC) levels.
    Time Frame
    12 weeks
    Title
    Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
    Description
    For UC patients, Clinician based Simple Clinical Colitis Activity Index (SCCAI) categorize two types of patients: patients with inactive disease (SCCAI score < 5) and patients with active disease (SCCAI score ≥ 5).
    Time Frame
    12 weeks
    Title
    Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
    Description
    by using Mayo score/disease activity index (Mayo/DAI) A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.
    Time Frame
    12 weeks
    Title
    Induction of disease remission (CD) by adding adjunct dietary interventions combined with pharmacotherapy.
    Description
    . For Crohn's disease patients, Modified Harvey Bradshaw Index will be used with score ≤ 5 indicate remission, =5-7mild disease ,8-16 moderate disease, ≥ 16 in severe disease.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
    Description
    will be at two points of time: after four weeks and after 12 weeks by using Mediterranean Diet Serving Score (MDSS) (16) for MD adherence.
    Time Frame
    12 Weeks
    Title
    Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
    Description
    will be at two points of time: after four weeks and after 12 weeks by using Anti- Inflammatory Diet Serving Score for IBD- AID adherence. The AID Serving Score (AIDSS) is based on the latest update of the Anti-Inflammatory Diet Pyramid, using the recommended consumption frequency of foods and food group.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Diagnosis of IBD (according to clinical, endoscopic and histological criteria). Receiving pharmacotherapy for IBD. Exclusion Criteria: Pediatric patients (less than 18 years old) Pregnant or breastfeeding patients Patients with concomitant alimentary tract disorders, such as malabsorption and celiac disease Patients requiring specific dietary interventions, such as diabetes mellitus, heart failure, renal failure, nephrosis, and liver failure, and neoplastic disorders.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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