Dietary Intervention for Inflammatory Bowel Disease Remission

NCT05920187 | Unknown

• 1 other identifier: dietary intervention in IBD
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.

  by standard biochemical procedures, such as C-reactive protein (CRP).

  12 weeks

• 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.

  12 weeks

• 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).

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

Secondary Outcomes (2)

• Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.

  12 Weeks

• Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.

  12 weeks

Study Arms (3)

Mediterranean diet group

ACTIVE COMPARATOR

following dietary intervention based on Mediterranean diet

Other: Mediterranean diet and Anti-inflammatory diet

Anti-inflammatory diet group

ACTIVE COMPARATOR

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

Other: Mediterranean diet and Anti-inflammatory diet

control group

NO INTERVENTION

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

Interventions

Mediterranean diet and Anti-inflammatory diet OTHER

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.

Also known as: MD and AID

Anti-inflammatory diet group; Mediterranean diet group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IBD (according to clinical, endoscopic and histological criteria).
• Receiving pharmacotherapy for IBD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Diet, Mediterranean; Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: June 27, 2023
• Study Start: July 15, 2023
• Primary Completion: July 15, 2025
• Study Completion: January 1, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share