NCT04882566

Brief Summary

Patients with inflammatory bowel disease (IBD) are increasingly becoming interested in nonpharmacologic approaches to their disease. One of the most frequently asked questions of IBD patients is what they should eat. The role of diet has become very important in the prevention and treatment of IBD. Although there is a general lack of rigorous scientific evidence that demonstrates which diet is best for certain patients, several diets have become popular. Aim of the Work To assess IBD patients' knowledge about the role of nutrition in the management of their Inflammatory Bowel Disease and the dietary beliefs, behaviors, and daily dietary practices in adult IBD patients that they make to avoid exacerbation of disease symptoms or to gain more control of bowel symptoms, keeping in mind our traditional and oriental food and food habits in Egypt. Also to evaluate the role of one of the most common dietary regimens; the Paleolithic diet in active mild or moderate inflammatory bowel disease.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

March 17, 2021

Last Update Submit

August 18, 2021

Conditions

Keywords

PaleolithicNutritionQuestionnaireInflammatory Bowel DiseaseNutritional assessmentUlcerative colitisCrohn's diseaseDiet

Outcome Measures

Primary Outcomes (1)

  • Evaluation of nutritional knowledge among IBD patients

    A self-administered questionnaire was formed of 30 questions assessing the following sub-domains. The questionnaire was developed after reviewing the literature on IBD patient's dietary habits, beliefs, therapies, and attitudes. Based on this literature study, relevant topics for the questionnaire were identified. Also, the draft questionnaire was thoroughly discussed with the IBD patient and modified because of practical aspects and face validity. The questionnaire included 30 close-ended questions, which were divided into 5 sub-domains: 1. General characteristics of the participants ( age, sex, residency, occupation, special habits, IBD type, IBD site in the GIT, disease activity, type of medication, and if there were any complications) 2. Nutritional knowledge 3. Dietary beliefs 4. Dietary behaviors and practices 5. The source of the dietary advice.

    1 year

Other Outcomes (4)

  • Role of Paleolithic diet in improving IBD patients symptoms

    1month

  • Role of Paleolithic diet in improving IBD patients Quality of Life

    1 month

  • Role of Paleolithic diet in induction of laboratory Remission by its effect on CRP

    1 month

  • +1 more other outcomes

Interventions

Advice to follow Paleolithic Diet for Inflammatory bowel disease Patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Inflammatory Bowel disease either Ulcerative colitis or Crohn's disease who are in remission and activity.

You may qualify if:

  • All patients diagnosed to have Inflammatory bowel disease either Crohn's disease or Ulcerative Colitis attending our Inflammatory bowel disease outpatient clinic at Al-Rajhy Liver Hospital for any reason, either in remission or in activity at Al-Rajhy Liver Hospital at Al-Rajhy Liver Hospital were included in our study.

You may not qualify if:

  • Severe disease and critical patients in the Intensive Care Unit with severe exacerbation were excluded from the study. Patients who were not surely diagnosed to have IBD were excluded from the study. Patients with pure perianal CD, a current stoma, previous extensive GI resection, or a current stricture were excluded. Patients were excluded if they had significant comorbidities, or if they were pregnant or lactating. Also, patients with any other acute illness and those who underwent gastrointestinal surgical interventions due to any cause were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Knight-Sepulveda K, Kais S, Santaolalla R, Abreu MT. Diet and Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 2015 Aug;11(8):511-20.

    PMID: 27118948BACKGROUND
  • Lee D, Albenberg L, Compher C, Baldassano R, Piccoli D, Lewis JD, Wu GD. Diet in the pathogenesis and treatment of inflammatory bowel diseases. Gastroenterology. 2015 May;148(6):1087-106. doi: 10.1053/j.gastro.2015.01.007. Epub 2015 Jan 15.

    PMID: 25597840BACKGROUND
  • Esmat S, El Nady M, Elfekki M, Elsherif Y, Naga M. Epidemiological and clinical characteristics of inflammatory bowel diseases in Cairo, Egypt. World J Gastroenterol. 2014 Jan 21;20(3):814-21. doi: 10.3748/wjg.v20.i3.814.

    PMID: 24574754BACKGROUND

MeSH Terms

Conditions

Colitis, UlcerativeCrohn DiseaseInflammatory Bowel Diseases

Interventions

Diet, Paleolithic

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kerollos L Labib, MSC

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Kerollos L Labib, MSC

CONTACT

Manal Ez Eldeen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator of Internal Medicine department

Study Record Dates

First Submitted

March 17, 2021

First Posted

May 12, 2021

Study Start

August 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share