Clinical trial NCT05920187: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. 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.
2. 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.

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.

Primary outcomes:
measure: Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
timeFrame: 12 weeks
measure: Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
timeFrame: 12 weeks
measure: Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
timeFrame: 12 weeks
measure: Induction of disease remission (UC) by adding adjunct dietary interventions combined with pharmacotherapy.
timeFrame: 12 weeks
measure: Induction of disease remission (CD) by adding adjunct dietary interventions combined with pharmacotherapy.
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
timeFrame: 12 Weeks
measure: Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
timeFrame: 12 weeks
Other outcomes:
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