Inflammatory Bowel DiseasesNCT05920187
Dietary Intervention for Inflammatory Bowel Disease Remission
A study testing Mediterranean diet and Anti-inflammatory diet in people with Inflammatory Bowel Diseases, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Mediterranean diet and Anti-inflammatory diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2023to 1 Jan 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Diagnosis of IBD (according to clinical, endoscopic and histological criteria).
- Receiving pharmacotherapy for IBD.
Who cannot join
- 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.
About this study
Official title: Additive Modified Mediterranean Dietary Intervention Versus Modified Anti-inflammatory Dietary Intervention for Inflammatory Bowel Disease Remission
- 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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Mediterranean diet and Anti-inflammatory diet
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet and Anti-inflammatory dietOther
Also called MD and AID
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.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Active comparator | following dietary intervention based on Mediterranean diet Receives: Other: Mediterranean diet and Anti-inflammatory diet |
| Anti-inflammatory diet group | Active comparator | following dietary intervention based on IBD-Anti-inflammatory diet. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
by standard biochemical procedures, such as C-reactive protein (CRP).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 Weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start15 Jul 2023 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Khaled Mostafa Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920187
- Sponsor's protocol ID
- dietary intervention in IBD
- Status last verified
- Jun 2023
- First submitted
- 18 Mar 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Modified Mediterranean Dietary Intervention Versus Modified Anti-inflammatory Dietary Intervention for Inflammatory Bowel Disease Remission
- ClinicalTrials.gov ID
- NCT05920187
- Acronym / sponsor ID
- dietary intervention in IBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Jun 2023 (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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Active comparator | Other: Mediterranean diet and Anti-inflammatory dietfollowing dietary intervention based on Mediterranean diet |
| Anti-inflammatory diet group | Active comparator | Other: Mediterranean diet and Anti-inflammatory dietfollowing dietary intervention based on IBD-Anti-inflammatory diet. |
| control group | No intervention | –Patients of the control group will not be instructed to follow a specific dietary intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Diagnosis of IBD (according to clinical, endoscopic and histological criteria).
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Mediterranean diet and Anti-inflammatory dietAlso: MD and AIDCases 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. | Other | Anti-inflammatory diet group, Mediterranean diet group |
Primary outcome
Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
Time frame: 12 weeks
by standard biochemical procedures, such as C-reactive protein (CRP).
Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
. 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.
2 secondary outcomes
Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
Time frame: 12 Weeks
Adherence of IBD patients to adjunct dietary interventions, and its impact on induction of remission.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Anti-inflammatory diet in people with Inflammatory Bowel Diseases, 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 2 inclusion and 4 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 27 Jun 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction of disease remission by adding adjunct dietary interventions combined with pharmacotherapy. (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2023.