Inflammatory Bowel DiseasesNCT05877209
Screening of Nutritional Status and Sarcopenia Among Patients With IBD
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
1. Screening of malnutrition in patients with IBD and its relation to severity of the disease. 2. Determination of severity of malnutrition in IBD patients. 3. Assessment of Sarcopenia in patients with IBD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 1 Dec 2023
- 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
Who may be able to join
- Patients above the age of 18 years old and diagnosed to have IBD (UC or CD). The diagnosis of IBD will be based on clinical, laboratory, radiological, endoscopic and/or histopathological data.
- Naïve IBD patients or those currently on treatment
Who cannot join
- Patients undergoing intentional weight loss plan.
- Patients with Cardiac Diseases.
- Patients with Liver diseases
- Patients with Thyroid active diseases.
- Pregnant women with IBD.
- Diabetic patients.
- Patients with extra-intestinal malignancies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening of Nutritional Status and Sarcopenia Among Inflammatory Bowel Disease Patients in Assuit University Hospital
- Screening of malnutrition in patients with IBD and its relation to severity of the disease.
- Determination of severity of malnutrition in IBD patients.
- Assessment of Sarcopenia in patients with IBD.
Read the detailed description
Inflammatory bowel disease (IBD) encompasses Crohn's disease (CD) and ulcerative colitis (UC) is a chronic, relapsing, inflammatory disorder of the digestive tract that characteristically develops in adolescence and early adulthood. IBD is associated with inflammation and negative nutrient balance, which is a risk factor for malnutrition. Multiple definitions of malnutrition have been proposed in literature. The early definitions of malnutrition referred to a state of under nutrition. Subsequently, an imbalance of nutrients, either deficiency or excess, was included in the definition. World Health Organization (WHO) defines malnutrition as deficiency, excess, or imbalance in a person's intake of energy and/or nutrients. The reported prevalence of malnutrition in IBD varies between 16 % and 75%. Several studies have reported a prevalence of weight loss in 70%-80% of hospitalized IBD patients and in 20%-40% of outpatients with CD. Several factors contribute to malnutrition in IBD patients. It is known that a reduced oral food intake is a main determinant of malnutrition in patients with IBD. Several mechanisms are involved in the reduction of food intake. Patients with active IBD often experience loss of appetite due to nausea, vomiting, abdominal pain, and diarrhea. Medications may also induce nausea, vomiting, or anorexia. Glucocorticoids often reduce phosphorus, zinc, and calcium absorption and may lead to osteoporosis. Long-term sulfasalazine therapy, a folic acid antagonist, might be related to anemia. Hospitalization itself or prolonged restrictive diet may lead to a significant reduction of food intake. The severity of malnutrition in IBD patients is dependent on the activity, duration and extent of the disease. In particular, on the magnitude of the inflammatory systemic response mediated by pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF) and interleukins-1 and -6, which can increase catabolism and lead to anorexia. Sarcopenia has been defined by the European Working Group on Sarcopenia (EWGSOP) combining low muscle strength, low muscle quantity/quality, and low physical performance. There has been a major change from the original operational definition, as low muscle strength was added as a prerequisite to definitions based only on the detection of low muscle mass. In addition, low physical performance is considered a predictor for poor outcomes; thus, such measures are useful to classify the severity of sarcopenia. Nutritional status is traditionally measured with anthropometric tests including height, weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skinfold thickness. These parameters improve with IBD treatment but may not reflect changes in body composition. The purpose of the NRS-2002 system is to detect the presence of under nutrition and the risk of developing under nutrition in the hospital setting. It contains the nutritional components of Malnutrition Universal Screening Test (MUST). In addition, a grading of severity of disease as a reflection of increased nutritional requirements. With the prototypes for severity of disease given, it is meant to cover all possible patient categories in a hospital.
- Conditions
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening of malnutrition in patients with IBD using and its relation to severity of the disease.
screening of malnutrition in patients with IBD using Nutritional Risk Screening score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ahmed Mohamed Refaat Askalany, Assiut University
- Investigators
- Sherif Kamel, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877209
- Sponsor's protocol ID
- NRS score in IBD
- Status last verified
- May 2023
- First submitted
- 2 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goh J, O'Morain CA. Review article: nutrition and adult inflammatory bowel disease. Aliment Pharmacol Ther. 2003 Feb;17(3):307-20. doi: 10.1046/j.1365-2036.2003.01482.x.
PubMed 12562443Donnellan CF, Yann LH, Lal S. Nutritional management of Crohn's disease. Ther Adv Gastroenterol. 2013 May;6(3):231-42. doi: 10.1177/1756283X13477715.
PubMed 23634187Casanova MJ, Chaparro M, Molina B, Merino O, Batanero R, Duenas-Sadornil C, Robledo P, Garcia-Albert AM, Gomez-Sanchez MB, Calvet X, Trallero MDR, Montoro M, Vazquez I, Charro M, Barragan A, Martinez-Cerezo F, Megias-Rangil I, Huguet JM, Marti-Bonmati E, Calvo M, Campdera M, Munoz-Vicente M, Merchante A, Avila AD, Serrano-Aguayo P, De Francisco R, Hervias D, Bujanda L, Rodriguez GE, Castro-Laria L, Barreiro-de Acosta M, Van Domselaar M, Ramirez de la Piscina P, Santos-Fernandez J, Algaba A, Torra S, Pozzati L, Lopez-Serrano P, Arribas MDR, Rincon ML, Pelaez AC, Castro E, Garcia-Herola A, Santander C, Hernandez-Alonso M, Martin-Noguerol E, Gomez-Lozano M, Monedero T, Villoria A, Figuerola A, Castano-Garcia A, Banales JM, Diaz-Hernandez L, Arguelles-Arias F, Lopez-Diaz J, Perez-Martinez I, Garcia-Talavera N, Nuevo-Siguairo OK, Riestra S, Gisbert JP. Prevalence of Malnutrition and Nutritional Characteristics of Patients With Inflammatory Bowel Disease. J Crohns Colitis. 2017 Dec 4;11(12):1430-1439. doi: 10.1093/ecco-jcc/jjx102.
PubMed 28981652Unal NG, Oruc N, Tomey O, Omer Ozutemiz A. Malnutrition and sarcopenia are prevalent among inflammatory bowel disease patients with clinical remission. Eur J Gastroenterol Hepatol. 2021 Nov 1;33(11):1367-1375. doi: 10.1097/MEG.0000000000002044.
PubMed 33470696Lanfranchi GA, Brignola C, Campieri M, Bazzocchi G, Pasquali R, Bassein L, Labo G. Assessment of nutritional status in Crohn's disease in remission or low activity. Hepatogastroenterology. 1984 Jun;31(3):129-32.
PubMed 6469202Hartman C, Eliakim R, Shamir R. Nutritional status and nutritional therapy in inflammatory bowel diseases. World J Gastroenterol. 2009 Jun 7;15(21):2570-8. doi: 10.3748/wjg.15.2570.
PubMed 19496185Hanauer SB, Stathopoulos G. Risk-benefit assessment of drugs used in the treatment of inflammatory bowel disease. Drug Saf. 1991 May-Jun;6(3):192-219. doi: 10.2165/00002018-199106030-00005.
PubMed 1676590Singleton JW, Law DH, Kelley ML Jr, Mekhjian HS, Sturdevant RA. National Cooperative Crohn's Disease Study: adverse reactions to study drugs. Gastroenterology. 1979 Oct;77(4 Pt 2):870-82.
PubMed 38177Hebuterne X, Filippi J, Al-Jaouni R, Schneider S. Nutritional consequences and nutrition therapy in Crohn's disease. Gastroenterol Clin Biol. 2009 Jun;33 Suppl 3:S235-44. doi: 10.1016/S0399-8320(09)73159-8.
PubMed 20117347Lucendo AJ, De Rezende LC. Importance of nutrition in inflammatory bowel disease. World J Gastroenterol. 2009 May 7;15(17):2081-8. doi: 10.3748/wjg.15.2081.
PubMed 19418580Cabre E, Gassull MA. Nutrition in inflammatory bowel disease: impact on disease and therapy. Curr Opin Gastroenterol. 2001 Jul;17(4):342-9. doi: 10.1097/00001574-200107000-00008.
PubMed 17031181Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
PubMed 31081853Gerasimidis K, McGrogan P, Edwards CA. The aetiology and impact of malnutrition in paediatric inflammatory bowel disease. J Hum Nutr Diet. 2011 Aug;24(4):313-26. doi: 10.1111/j.1365-277X.2011.01171.x. Epub 2011 May 13.
PubMed 21564345Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
PubMed 12765673
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Nutritional Status and Sarcopenia Among Inflammatory Bowel Disease Patients in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT05877209
- Acronym / sponsor ID
- NRS score in IBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 May 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.
- Screening of malnutrition in patients with IBD and its relation to severity of the disease.
- Determination of severity of malnutrition in IBD patients.
- Assessment of Sarcopenia in patients with IBD.
Detailed description
Inflammatory bowel disease (IBD) encompasses Crohn's disease (CD) and ulcerative colitis (UC) is a chronic, relapsing, inflammatory disorder of the digestive tract that characteristically develops in adolescence and early adulthood. IBD is associated with inflammation and negative nutrient balance, which is a risk factor for malnutrition. Multiple definitions of malnutrition have been proposed in literature. The early definitions of malnutrition referred to a state of under nutrition. Subsequently, an imbalance of nutrients, either deficiency or excess, was included in the definition. World Health Organization (WHO) defines malnutrition as deficiency, excess, or imbalance in a person's intake of energy and/or nutrients. The reported prevalence of malnutrition in IBD varies between 16 % and 75%. Several studies have reported a prevalence of weight loss in 70%-80% of hospitalized IBD patients and in 20%-40% of outpatients with CD. Several factors contribute to malnutrition in IBD patients. It is known that a reduced oral food intake is a main determinant of malnutrition in patients with IBD. Several mechanisms are involved in the reduction of food intake. Patients with active IBD often experience loss of appetite due to nausea, vomiting, abdominal pain, and diarrhea. Medications may also induce nausea, vomiting, or anorexia. Glucocorticoids often reduce phosphorus, zinc, and calcium absorption and may lead to osteoporosis. Long-term sulfasalazine therapy, a folic acid antagonist, might be related to anemia. Hospitalization itself or prolonged restrictive diet may lead to a significant reduction of food intake. The severity of malnutrition in IBD patients is dependent on the activity, duration and extent of the disease. In particular, on the magnitude of the inflammatory systemic response mediated by pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF) and interleukins-1 and -6, which can increase catabolism and lead to anorexia. Sarcopenia has been defined by the European Working Group on Sarcopenia (EWGSOP) combining low muscle strength, low muscle quantity/quality, and low physical performance. There has been a major change from the original operational definition, as low muscle strength was added as a prerequisite to definitions based only on the detection of low muscle mass. In addition, low physical performance is considered a predictor for poor outcomes; thus, such measures are useful to classify the severity of sarcopenia. Nutritional status is traditionally measured with anthropometric tests including height, weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skinfold thickness. These parameters improve with IBD treatment but may not reflect changes in body composition. The purpose of the NRS-2002 system is to detect the presence of under nutrition and the risk of developing under nutrition in the hospital setting. It contains the nutritional components of Malnutrition Universal Screening Test (MUST). In addition, a grading of severity of disease as a reflection of increased nutritional requirements. With the prototypes for severity of disease given, it is meant to cover all possible patient categories in a hospital.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with inflammatory bowel disease
Key inclusion criteria (2 listed)
- Patients above the age of 18 years old and diagnosed to have IBD (UC or CD). The diagnosis of IBD will be based on clinical, laboratory, radiological, endoscopic and/or histopathological data.
- Naïve IBD patients or those currently on treatment
Key exclusion criteria (7 listed)
- Patients undergoing intentional weight loss plan.
- Patients with Cardiac Diseases.
- Patients with Liver diseases
- Patients with Thyroid active diseases.
- Pregnant women with IBD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening of malnutrition in patients with IBD using and its relation to severity of the disease.
Time frame: Baseline
screening of malnutrition in patients with IBD using Nutritional Risk Screening score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 12562443Goh J, O'Morain CA. Review article: nutrition and adult inflammatory bowel disease. Aliment Pharmacol Ther. 2003 Feb;17(3):307-20. doi: 10.1046/j.1365-2036.2003.01482.x.
- Background: PubMed 23634187Donnellan CF, Yann LH, Lal S. Nutritional management of Crohn's disease. Ther Adv Gastroenterol. 2013 May;6(3):231-42. doi: 10.1177/1756283X13477715.
- Background: PubMed 28981652Casanova MJ, Chaparro M, Molina B, Merino O, Batanero R, Duenas-Sadornil C, Robledo P, Garcia-Albert AM, Gomez-Sanchez MB, Calvet X, Trallero MDR, Montoro M, Vazquez I, Charro M, Barragan A, Martinez-Cerezo F, Megias-Rangil I, Huguet JM, Marti-Bonmati E, Calvo M, Campdera M, Munoz-Vicente M, Merchante A, Avila AD, Serrano-Aguayo P, De Francisco R, Hervias D, Bujanda L, Rodriguez GE, Castro-Laria L, Barreiro-de Acosta M, Van Domselaar M, Ramirez de la Piscina P, Santos-Fernandez J, Algaba A, Torra S, Pozzati L, Lopez-Serrano P, Arribas MDR, Rincon ML, Pelaez AC, Castro E, Garcia-Herola A, Santander C, Hernandez-Alonso M, Martin-Noguerol E, Gomez-Lozano M, Monedero T, Villoria A, Figuerola A, Castano-Garcia A, Banales JM, Diaz-Hernandez L, Arguelles-Arias F, Lopez-Diaz J, Perez-Martinez I, Garcia-Talavera N, Nuevo-Siguairo OK, Riestra S, Gisbert JP. Prevalence of Malnutrition and Nutritional Characteristics of Patients With Inflammatory Bowel Disease. J Crohns Colitis. 2017 Dec 4;11(12):1430-1439. doi: 10.1093/ecco-jcc/jjx102.
- Background: PubMed 33470696Unal NG, Oruc N, Tomey O, Omer Ozutemiz A. Malnutrition and sarcopenia are prevalent among inflammatory bowel disease patients with clinical remission. Eur J Gastroenterol Hepatol. 2021 Nov 1;33(11):1367-1375. doi: 10.1097/MEG.0000000000002044.
- Background: PubMed 6469202Lanfranchi GA, Brignola C, Campieri M, Bazzocchi G, Pasquali R, Bassein L, Labo G. Assessment of nutritional status in Crohn's disease in remission or low activity. Hepatogastroenterology. 1984 Jun;31(3):129-32.
- Background: PubMed 19496185Hartman C, Eliakim R, Shamir R. Nutritional status and nutritional therapy in inflammatory bowel diseases. World J Gastroenterol. 2009 Jun 7;15(21):2570-8. doi: 10.3748/wjg.15.2570.
- Background: PubMed 1676590Hanauer SB, Stathopoulos G. Risk-benefit assessment of drugs used in the treatment of inflammatory bowel disease. Drug Saf. 1991 May-Jun;6(3):192-219. doi: 10.2165/00002018-199106030-00005.
- Background: PubMed 38177Singleton JW, Law DH, Kelley ML Jr, Mekhjian HS, Sturdevant RA. National Cooperative Crohn's Disease Study: adverse reactions to study drugs. Gastroenterology. 1979 Oct;77(4 Pt 2):870-82.
- Background: PubMed 20117347Hebuterne X, Filippi J, Al-Jaouni R, Schneider S. Nutritional consequences and nutrition therapy in Crohn's disease. Gastroenterol Clin Biol. 2009 Jun;33 Suppl 3:S235-44. doi: 10.1016/S0399-8320(09)73159-8.
- Background: PubMed 19418580Lucendo AJ, De Rezende LC. Importance of nutrition in inflammatory bowel disease. World J Gastroenterol. 2009 May 7;15(17):2081-8. doi: 10.3748/wjg.15.2081.
- Background: PubMed 17031181Cabre E, Gassull MA. Nutrition in inflammatory bowel disease: impact on disease and therapy. Curr Opin Gastroenterol. 2001 Jul;17(4):342-9. doi: 10.1097/00001574-200107000-00008.
- Background: PubMed 31081853Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
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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.
Sherif Kamel, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of 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 7 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 26 May 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?
Contact Noha Askalany, Bachelor (00201050028350, noha.askalany@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening of malnutrition in patients with IBD using and its relation to severity of the disease. (time frame: Baseline). 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 NCT05877209, which also lists 14 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 26 May 2023.