Ulcerative ColitisNCT04882566
Assessment of Nutritional Knowledge in Patients With Inflammatory Bowel Disease
An observational study of Ulcerative Colitis and Crohn Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Nutrition
- What is being tested?
- Paleolithic Diet
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with Inflammatory Bowel disease either Ulcerative colitis or Crohn's disease who are in remission and activity.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic auto-immune disorder with unclear etiology. Multiple factors play a role in the patho¬genesis of IBD. These may include diet, environmental factors, immunologic factors, infectious agents, genetic susceptibility, and the microbiome. The emergence of rapid increases in the incidence of IBD over the past several decades in low-incidence parts of the world, clearly points to the important role that the environment plays in disease develop¬ment.
In Egypt, it was noticed a marked increase in the frequency of both UC and CD diagnoses during the most recent 10 years from 1995 to 2009 and it is still rising till now .
Therefore, clinicians, along with patients, have questioned whether diet influences the onset, prognosis, and the need of drug intensification ( Figure 2 ). The ques¬tion of what to eat is the most commonly encountered question as well as the most challenging one asked to gastroenterologists managing IBD patients. At present, there is no specific IBD diet that is supported by robust data, leaving patients to seek nonmedical resources for dietary advice. Dietary intervention trials have been limited by their lack of a placebo control group and the difficulty in meticulously capturing dietary intake conjointly with the potential for complex interactions between foods. Furthermore, dietary trials may not detect significant dif¬ferences for patients undergoing withdrawal of specific drug therapies.
The lay literature has promoted several popular diets that have been touted to alleviate intestinal inflammation and have thereby been advocated for patients with IBD. These include the specific carbohydrate diet (SCD); the low-fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (Low-FODMAP) diet; the Paleolithic diet (Paleo); and the anti-inflamma¬tory diet (IBD-AID). As patients look to complementary therapies for the management of their disease, clinicians must understand the effectiveness and the role of these dietary interventions to advise and direct patients So that it's clear that access to proper dietary guidance is an essential part of dietary self-management in IBD.However, patients learn about their food tolerances and intolerances by trial and error rather than under the guidance of a health professional. This creates the risk of (micro) nutrient deficiencies in the case of uninformed or badly informed food avoidance and strict diets. Moreover, there is no guarantee that the best possible measures are taken to control the bowel disorder. There is, however, evidence that the effectiveness of personal diets could be improved by the guidance of a professional dietary IBD service.
As a start, it is important to learn more about the current practices and beliefs of IBD patients concerning their diet.
- Conditions
- Ulcerative Colitis, Crohn Disease, Nutrition
- Being tested
- Paleolithic Diet
- Keywords
- Paleolithic, Nutrition, Questionnaire, Inflammatory Bowel Disease, Nutritional assessment, Ulcerative colitis, Crohn's disease, Diet
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paleolithic DietOther
Advice to follow Paleolithic Diet for Inflammatory bowel disease Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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)
- Nutritional knowledge
- Dietary beliefs
- Dietary behaviors and practices
- The source of the dietary advice.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study startAug 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Latif Labib, Assiut University
- Investigators
- Kerollos L Labib, MSC, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882566
- Sponsor's protocol ID
- Nutrition in IBD patients
- Status last verified
- Aug 2021
- First submitted
- 17 Mar 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knight-Sepulveda K, Kais S, Santaolalla R, Abreu MT. Diet and Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 2015 Aug;11(8):511-20.
PubMed 27118948Lee 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.
PubMed 25597840Esmat 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.
PubMed 24574754
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Knowledge in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04882566
- Acronym / sponsor ID
- Nutrition in IBD patients
- Conditions
- Ulcerative Colitis, Crohn Disease, Nutrition
- Keywords
- Paleolithic, Nutrition, Questionnaire, Inflammatory Bowel Disease, Nutritional assessment, Ulcerative colitis, Crohn's disease, Diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inflammatory bowel disease (IBD) is a chronic auto-immune disorder with unclear etiology. Multiple factors play a role in the patho¬genesis of IBD. These may include diet, environmental factors, immunologic factors, infectious agents, genetic susceptibility, and the microbiome. The emergence of rapid increases in the incidence of IBD over the past several decades in low-incidence parts of the world, clearly points to the important role that the environment plays in disease develop¬ment.
In Egypt, it was noticed a marked increase in the frequency of both UC and CD diagnoses during the most recent 10 years from 1995 to 2009 and it is still rising till now .
Therefore, clinicians, along with patients, have questioned whether diet influences the onset, prognosis, and the need of drug intensification ( Figure 2 ). The ques¬tion of what to eat is the most commonly encountered question as well as the most challenging one asked to gastroenterologists managing IBD patients. At present, there is no specific IBD diet that is supported by robust data, leaving patients to seek nonmedical resources for dietary advice. Dietary intervention trials have been limited by their lack of a placebo control group and the difficulty in meticulously capturing dietary intake conjointly with the potential for complex interactions between foods. Furthermore, dietary trials may not detect significant dif¬ferences for patients undergoing withdrawal of specific drug therapies.
The lay literature has promoted several popular diets that have been touted to alleviate intestinal inflammation and have thereby been advocated for patients with IBD. These include the specific carbohydrate diet (SCD); the low-fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (Low-FODMAP) diet; the Paleolithic diet (Paleo); and the anti-inflamma¬tory diet (IBD-AID). As patients look to complementary therapies for the management of their disease, clinicians must understand the effectiveness and the role of these dietary interventions to advise and direct patients So that it's clear that access to proper dietary guidance is an essential part of dietary self-management in IBD.However, patients learn about their food tolerances and intolerances by trial and error rather than under the guidance of a health professional. This creates the risk of (micro) nutrient deficiencies in the case of uninformed or badly informed food avoidance and strict diets. Moreover, there is no guarantee that the best possible measures are taken to control the bowel disorder. There is, however, evidence that the effectiveness of personal diets could be improved by the guidance of a professional dietary IBD service.
As a start, it is important to learn more about the current practices and beliefs of IBD patients concerning their diet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with Inflammatory Bowel disease either Ulcerative colitis or Crohn's disease who are in remission and activity.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paleolithic DietAdvice to follow Paleolithic Diet for Inflammatory bowel disease Patients | Other | – |
Primary outcome
Evaluation of nutritional knowledge among IBD patients
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Background: PubMed 27118948Knight-Sepulveda K, Kais S, Santaolalla R, Abreu MT. Diet and Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 2015 Aug;11(8):511-20.
- Background: PubMed 25597840Lee 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.
- Background: PubMed 24574754Esmat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerollos L Labib, MSC study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerollos L Labib, MSC (01277111356, dr.kerolloslatuf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of nutritional knowledge among IBD patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882566, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.