Inflammatory Bowel DiseasesNUTRICO-IBDNCT06550310
Nutrition and Clinical Outcomes in IBD
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to demonstrate that nutritional status and body composition have an impact on clinical outcomes in inflammatory bowel disease (IBD). The main objectives are: 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults (>16) with a diagnosis of inflammatory bowel disease (IBD) attending a tertiary IBD centre who are undergoing a new treatment or change in treatment, or an operation for their condition
Who may be able to join
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery
- Age >16
- Patients able and willing to provide written informed consent
Who cannot join
- Patients below the age of 16
- Patients who cannot provide informed consent
- Patients with a cardiac pacemaker or internal defibrillator
- Patients with active cancer and other disorders associated with severe cachexia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Barts Health NHS Trust
London, N15 4GL
Sarah C Faloon, 07713444631, sarah.faloon@nhs.net
About this study
Official title: Nutrition and Body Composition and Association With Clinical Outcomes in Inflammatory Bowel Disease
The goal of this observational study is to demonstrate that nutritional status and body composition have an impact on clinical outcomes in inflammatory bowel disease (IBD).
The main objectives are:
Read more
- To compare the detection rates of undernutrition between a range of nutritional screening tools, physiological measures and assessment tools amongst patients with different IBD phenotypes
- To correlate nutritional status, nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
- To determine a potential relationship between radiological muscle mass measurements and clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
Participants will undergo an assessment at pre-treatment baseline and then again at their scheduled follow-up. This is a non-interventional study and participants will not be required to have any invasive tests or hospital visits beyond that of standard clinical care.
Read the detailed description
Background and Rationale:
Inflammatory bowel disease (IBD) comprises Crohn's disease (CD) and ulcerative colitis (UC). It affects nearly 400,000 people in the United Kingdom (UK) and the global prevalence is rising. Many patients suffer an impaired quality of life. Whilst advanced medical therapies are being used more often, the lifetime risk of surgery is as high as 70%. Unfortunately, loss of response to medical therapies and post-operative complications remain major clinical challenges. Risk factors for adverse treatment outcomes include disease duration, emergency surgery and undernutrition. Not only is undernutrition a risk factor for adverse clinical outcomes, it is present in up to 36% of patients with IBD. Crucially, unlike other risk factors, it is also modifiable with cheap and safe interventions. It therefore presents an ideal opportunity for intervention. Despite this, current methods of detecting undernutrition in IBD are unfit for purpose.
Body composition (BC) analysis is emerging as a highly clinically relevant physiological marker in IBD. Skeletal muscle loss with functional impairment (sarcopenia) in IBD patients is associated with a range of outcomes including disease flares, hospitalisation, need for surgery and need for ICU admissions. Radiological measurement of skeletal muscle index (SMI) at the level of the 3rd lumbar vertebra is objective and reproducible. Validated software designed specifically for this purpose (Slice-o-Matic [Tomovision, Canada]) can be used on CT/MRI scans which are often performed as part of standard IBD care. However, despite this, BC analysis by any method is not performed in routine clinical practice. The most commonly used physiological markers in the UK remain weight and body mass index (BMI), which do not provide any measure of BC.
Overall, there remains uncertainty over which nutritional tools should be used in patients with IBD. Most studies have been small, retrospective and heterogenous. No study has performed a comparative analysis of more than three measurements in the same patient cohort. Evidence of the ability of widely used nutritional screening tools to identify IBD patients most at risk of adverse clinical outcomes is lacking. Finally, there is little data describing the performance of different tools and measures according to disease phenotype and disease activity. This study proposes to meet this knowledge gap by comparing a range of nutritional tools in a large, prospective, well-phenotyped IBD cohort.
Study design:
Eligible patients will be identified from dedicated IBD multi-disciplinary weekly meetings, IBD clinic, medical infusion suites and the medical records. The clinical team will be aware of the study and can also flag potential eligible patients to the investigators. Participants will be contacted or approached directly in clinic or via telephone.
This will be a prospective, non-interventional study performed at Barts Health National Health Service (NHS) Trust over 4 years. For patients treated with advanced medical therapies, the entire prospective dataset will be collected at a pre-treatment baseline (within 4 weeks before treatment) and at weeks 14 and 52 after therapy commencement. For patients undergoing surgery, data will be collected at a pre-operative baseline (within 4 weeks before surgery) and at 3 months post-operatively. Data relating to dietetic input and artificial nutritional support will be included. The following outcomes from medical therapy will be collected at weeks 14 and 52: clinical response, clinical and biochemical remission, corticosteroid use, therapy switch, IBD-surgery. The following surgical outcomes will be collected: length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate. Participants will then be followed-up longitudinally over the aforementioned defined timepoints. Muscle mass measurements will be performed by exporting CT/MRI image slices at the level of the third vertebra from Trust computers and using Slice-O-Matic software to measure skeletal muscle indices (SMI). Additionally, we will access de-identified CT/MRI scans from 946 well-phenotyped patients who have undergone IBD surgery collected by the national UK IBD Bioresource and made available via the Gut Reaction initiative hosted by the National Institute for Health and Care Research (NIHR). Post-operative outcome data will also be available, enabling this to be used as an external validation cohort to the primary surgical dataset. Within the internal cohort, handgrip strength and timed up and go test (TUG) or gait speed will be performed prospectively at scheduled visits, to assess muscle strength and physical performance respectively. All nutritional parameters collected will be correlated with clinical outcomes.
The clinical data that will be collected is outlined below:
Demographics: age, gender, ethnicity, comorbidities, smoking status, postcode IBD phenotype: diagnosis, duration, disease location and behaviour (CD), disease extent (UC) IBD treatment: current IBD therapy (>3 months), previous IBD therapy, previous IBD-related surgery IBD activity: Harvey Bradshaw Index (HBI) or partial Mayo scores, C-reactive protein (CRP), faecal calprotectin Nutritional screening tools: Malnutrition Universal Screening Tool (MUST), Nutrition Risk Screening Tool-2002 (NRS-2002), Malnutrition Inflammation Risk Tool (MIRT) Nutritional assessment tools: Subjective Global Assessment (SGA), Global Leadership Initiative on Malnutrition (GLIM) criteria Weight, height, BMI, anthropometry (waist circumference, mid-upper arm circumference, triceps skinfold thickness, mid-arm muscle circumference) Handgrip strength Timed up and go test (TUG) or gait speed Bioelectrical impedance analysis, including skeletal muscle mass (kg), body fat (%) and visceral adiposity (kg) Blood tests: Haemoglobin, folate, ferritin, B12, vitamin D, zinc, copper, selenium Dietetics: dietetic review, special diets, presence and type of artificial nutritional support Food intake (24-hour food diaries) Food frequency questionnaire Food-related quality of life questionnaire Skeletal muscle index
The end of recruitment will be month 18 for the medical arm and month 27 for the surgical arm, to allow sufficient time for follow-up and data analysis. The End of Study will be defined as the conclusion of follow-up monitoring, data analysis and write-up at month 36.
Analysis:
Descriptive statistics will be taken at baseline for both medical and surgical cohorts. These exploratory variables will be measured at the three timepoints (as outlined above) to compare if any statistically significant difference is present. Statistical significance will be considered if a threshold of p=0.05. One-way repeated measures analysis of variance (ANOVA) will be performed for both groups.
Further sub-group analysis to determine correlations between the exploratory variables and outcomes will be performed using multi-linear and binary logistic regression. Standard demographical analysis will be collected and further sub-group analysis based on ethnicity may be performed.
Ethical approval has been obtained from the Health Research Authority.
This study is sponsored by Barts Health NHS Trust.
There are no conflicts of interest.
- Keywords
- Body composition, Nutritional status, Nutritional markers, Nutritional screening tools, Nutritional assessment, Sarcopenia, Radiological muscle mass, Inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment group | Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy (e.g. biologic or small molecule) | |
| Surgical treatment group | Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).
Clinical outcomes are as follows clinical response, clinical and biochemical remission, corticosteroid use, therapy switch or IBD related-surgery.
Clinical response in UC is defined as a ≥2-point and ≥30% decrease from baseline in partial Mayo score and a ≥1-point decrease from baseline in rectal bleeding sub-score or an absolute rectal bleeding sub-score ≤1. Clinical response in CD is defined as ≥ 3 points decrease of HBI score. Clinical remission is defined as a partial Mayo score of 0-1 in UC or HBI of ≤4 in CD. Biochemical remission is defined as faecal calprotectin <200μg/mg and CRP ≤5mg/L.
Measured: 14 and 52 weeks
Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing IBD-related surgery (at 30 and 90 days).
Clinical outcomes are defined as length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate.
Measured: 30 and 90 days
Secondary outcomes (2)
Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).
Clinical outcomes are as follows clinical response, clinical and biochemical remission, corticosteroid use, therapy switch or IBD related-surgery.
Clinical response in UC is defined as a ≥2-point and ≥30% decrease from baseline in partial Mayo score and a ≥1-point decrease from baseline in rectal bleeding sub-score or an absolute rectal bleeding sub-score ≤1. Clinical response in CD is defined as ≥ 3 points decrease of HBI score. Clinical remission is defined as a partial Mayo score of 0-1 in UC or HBI of ≤4 in CD. Biochemical remission is defined as faecal calprotectin <200μg/mg and CRP ≤5mg/L.
Measured: 14 and 52 weeks
Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced IBD-related surgery (at 30 and 90 days).
Clinical outcomes are defined as length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate.
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start24 Oct 2024
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Shameer Mehta, MD, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550310
- Sponsor's protocol ID
- 337108
- Acronym
- NUTRICO-IBD
- Status last verified
- Feb 2026
- First submitted
- 31 Jul 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.
PubMed 31648971Knowles SR, Graff LA, Wilding H, Hewitt C, Keefer L, Mikocka-Walus A. Quality of Life in Inflammatory Bowel Disease: A Systematic Review and Meta-analyses-Part I. Inflamm Bowel Dis. 2018 Mar 19;24(4):742-751. doi: 10.1093/ibd/izx100.
PubMed 29562277Lewis RT, Maron DJ. Efficacy and complications of surgery for Crohn's disease. Gastroenterol Hepatol (N Y). 2010 Sep;6(9):587-96.
PubMed 21088749Gklavas A, Dellaportas D, Papaconstantinou I. Risk factors for postoperative recurrence of Crohn's disease with emphasis on surgical predictors. Ann Gastroenterol. 2017;30(6):598-612. doi: 10.20524/aog.2017.0195. Epub 2017 Sep 26.
PubMed 29118554Ma C, Moran GW, Benchimol EI, Targownik LE, Heitman SJ, Hubbard JN, Seow CH, Novak KL, Ghosh S, Panaccione R, Kaplan GG. Surgical Rates for Crohn's Disease are Decreasing: A Population-Based Time Trend Analysis and Validation Study. Am J Gastroenterol. 2017 Dec;112(12):1840-1848. doi: 10.1038/ajg.2017.394. Epub 2017 Oct 31.
PubMed 29087396Ananthakrishnan AN, Shi HY, Tang W, Law CC, Sung JJ, Chan FK, Ng SC. Systematic Review and Meta-analysis: Phenotype and Clinical Outcomes of Older-onset Inflammatory Bowel Disease. J Crohns Colitis. 2016 Oct;10(10):1224-36. doi: 10.1093/ecco-jcc/jjw054. Epub 2016 Feb 29.
PubMed 26928965Nguyen GC, Munsell M, Harris ML. Nationwide prevalence and prognostic significance of clinically diagnosable protein-calorie malnutrition in hospitalized inflammatory bowel disease patients. Inflamm Bowel Dis. 2008 Aug;14(8):1105-11. doi: 10.1002/ibd.20429.
PubMed 18302272Ananthakrishnan AN, McGinley EL, Binion DG, Saeian K. A novel risk score to stratify severity of Crohn's disease hospitalizations. Am J Gastroenterol. 2010 Aug;105(8):1799-807. doi: 10.1038/ajg.2010.105. Epub 2010 Mar 9.
PubMed 20216534Ciocirlan M, Ciocirlan M, Iacob R, Tantau A, Gheorghe L, Gheorghe C, Dobru D, Constantinescu G, Cijevschi C, Trifan A, Goldis A, Diculescu M. Malnutrition Prevalence in Newly Diagnosed Patients with Inflammatory Bowel Disease - Data from the National Romanian Database. J Gastrointestin Liver Dis. 2019 Jun 1;28:163-168. doi: 10.15403/jgld-176.
PubMed 31204412Casanova 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 28981652Bamba S, Sasaki M, Takaoka A, Takahashi K, Imaeda H, Nishida A, Inatomi O, Sugimoto M, Andoh A. Sarcopenia is a predictive factor for intestinal resection in admitted patients with Crohn's disease. PLoS One. 2017 Jun 23;12(6):e0180036. doi: 10.1371/journal.pone.0180036. eCollection 2017.
PubMed 28644887Zhang T, Cao L, Cao T, Yang J, Gong J, Zhu W, Li N, Li J. Prevalence of Sarcopenia and Its Impact on Postoperative Outcome in Patients With Crohn's Disease Undergoing Bowel Resection. JPEN J Parenter Enteral Nutr. 2017 May;41(4):592-600. doi: 10.1177/0148607115612054. Epub 2015 Oct 15.
PubMed 26471990Pedersen M, Cromwell J, Nau P. Sarcopenia is a Predictor of Surgical Morbidity in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2017 Oct;23(10):1867-1872. doi: 10.1097/MIB.0000000000001166.
PubMed 28604415Peng P, Hyder O, Firoozmand A, Kneuertz P, Schulick RD, Huang D, Makary M, Hirose K, Edil B, Choti MA, Herman J, Cameron JL, Wolfgang CL, Pawlik TM. Impact of sarcopenia on outcomes following resection of pancreatic adenocarcinoma. J Gastrointest Surg. 2012 Aug;16(8):1478-86. doi: 10.1007/s11605-012-1923-5. Epub 2012 Jun 13.
PubMed 22692586Lomer MC, Gourgey R, Whelan K. Current practice in relation to nutritional assessment and dietary management of enteral nutrition in adults with Crohn's disease. J Hum Nutr Diet. 2014 Apr;27 Suppl 2:28-35. doi: 10.1111/jhn.12133. Epub 2013 Jun 13.
PubMed 23763616
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Body Composition and Association With Clinical Outcomes in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06550310
- Acronym / sponsor ID
- NUTRICO-IBD / 337108
- Keywords
- Body composition, Nutritional status, Nutritional markers, Nutritional screening tools, Nutritional assessment, Sarcopenia, Radiological muscle mass, Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Aug 2024 (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.
The goal of this observational study is to demonstrate that nutritional status and body composition have an impact on clinical outcomes in inflammatory bowel disease (IBD).
The main objectives are:
- To compare the detection rates of undernutrition between a range of nutritional screening tools, physiological measures and assessment tools amongst patients with different IBD phenotypes
- To correlate nutritional status, nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
- To determine a potential relationship between radiological muscle mass measurements and clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
Participants will undergo an assessment at pre-treatment baseline and then again at their scheduled follow-up. This is a non-interventional study and participants will not be required to have any invasive tests or hospital visits beyond that of standard clinical care.
Detailed description
Background and Rationale:
Inflammatory bowel disease (IBD) comprises Crohn's disease (CD) and ulcerative colitis (UC). It affects nearly 400,000 people in the United Kingdom (UK) and the global prevalence is rising. Many patients suffer an impaired quality of life. Whilst advanced medical therapies are being used more often, the lifetime risk of surgery is as high as 70%. Unfortunately, loss of response to medical therapies and post-operative complications remain major clinical challenges. Risk factors for adverse treatment outcomes include disease duration, emergency surgery and undernutrition. Not only is undernutrition a risk factor for adverse clinical outcomes, it is present in up to 36% of patients with IBD. Crucially, unlike other risk factors, it is also modifiable with cheap and safe interventions. It therefore presents an ideal opportunity for intervention. Despite this, current methods of detecting undernutrition in IBD are unfit for purpose.
Body composition (BC) analysis is emerging as a highly clinically relevant physiological marker in IBD. Skeletal muscle loss with functional impairment (sarcopenia) in IBD patients is associated with a range of outcomes including disease flares, hospitalisation, need for surgery and need for ICU admissions. Radiological measurement of skeletal muscle index (SMI) at the level of the 3rd lumbar vertebra is objective and reproducible. Validated software designed specifically for this purpose (Slice-o-Matic [Tomovision, Canada]) can be used on CT/MRI scans which are often performed as part of standard IBD care. However, despite this, BC analysis by any method is not performed in routine clinical practice. The most commonly used physiological markers in the UK remain weight and body mass index (BMI), which do not provide any measure of BC.
Overall, there remains uncertainty over which nutritional tools should be used in patients with IBD. Most studies have been small, retrospective and heterogenous. No study has performed a comparative analysis of more than three measurements in the same patient cohort. Evidence of the ability of widely used nutritional screening tools to identify IBD patients most at risk of adverse clinical outcomes is lacking. Finally, there is little data describing the performance of different tools and measures according to disease phenotype and disease activity. This study proposes to meet this knowledge gap by comparing a range of nutritional tools in a large, prospective, well-phenotyped IBD cohort.
Study design:
Eligible patients will be identified from dedicated IBD multi-disciplinary weekly meetings, IBD clinic, medical infusion suites and the medical records. The clinical team will be aware of the study and can also flag potential eligible patients to the investigators. Participants will be contacted or approached directly in clinic or via telephone.
This will be a prospective, non-interventional study performed at Barts Health National Health Service (NHS) Trust over 4 years. For patients treated with advanced medical therapies, the entire prospective dataset will be collected at a pre-treatment baseline (within 4 weeks before treatment) and at weeks 14 and 52 after therapy commencement. For patients undergoing surgery, data will be collected at a pre-operative baseline (within 4 weeks before surgery) and at 3 months post-operatively. Data relating to dietetic input and artificial nutritional support will be included. The following outcomes from medical therapy will be collected at weeks 14 and 52: clinical response, clinical and biochemical remission, corticosteroid use, therapy switch, IBD-surgery. The following surgical outcomes will be collected: length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate. Participants will then be followed-up longitudinally over the aforementioned defined timepoints. Muscle mass measurements will be performed by exporting CT/MRI image slices at the level of the third vertebra from Trust computers and using Slice-O-Matic software to measure skeletal muscle indices (SMI). Additionally, we will access de-identified CT/MRI scans from 946 well-phenotyped patients who have undergone IBD surgery collected by the national UK IBD Bioresource and made available via the Gut Reaction initiative hosted by the National Institute for Health and Care Research (NIHR). Post-operative outcome data will also be available, enabling this to be used as an external validation cohort to the primary surgical dataset. Within the internal cohort, handgrip strength and timed up and go test (TUG) or gait speed will be performed prospectively at scheduled visits, to assess muscle strength and physical performance respectively. All nutritional parameters collected will be correlated with clinical outcomes.
The clinical data that will be collected is outlined below:
Demographics: age, gender, ethnicity, comorbidities, smoking status, postcode IBD phenotype: diagnosis, duration, disease location and behaviour (CD), disease extent (UC) IBD treatment: current IBD therapy (>3 months), previous IBD therapy, previous IBD-related surgery IBD activity: Harvey Bradshaw Index (HBI) or partial Mayo scores, C-reactive protein (CRP), faecal calprotectin Nutritional screening tools: Malnutrition Universal Screening Tool (MUST), Nutrition Risk Screening Tool-2002 (NRS-2002), Malnutrition Inflammation Risk Tool (MIRT) Nutritional assessment tools: Subjective Global Assessment (SGA), Global Leadership Initiative on Malnutrition (GLIM) criteria Weight, height, BMI, anthropometry (waist circumference, mid-upper arm circumference, triceps skinfold thickness, mid-arm muscle circumference) Handgrip strength Timed up and go test (TUG) or gait speed Bioelectrical impedance analysis, including skeletal muscle mass (kg), body fat (%) and visceral adiposity (kg) Blood tests: Haemoglobin, folate, ferritin, B12, vitamin D, zinc, copper, selenium Dietetics: dietetic review, special diets, presence and type of artificial nutritional support Food intake (24-hour food diaries) Food frequency questionnaire Food-related quality of life questionnaire Skeletal muscle index
The end of recruitment will be month 18 for the medical arm and month 27 for the surgical arm, to allow sufficient time for follow-up and data analysis. The End of Study will be defined as the conclusion of follow-up monitoring, data analysis and write-up at month 36.
Analysis:
Descriptive statistics will be taken at baseline for both medical and surgical cohorts. These exploratory variables will be measured at the three timepoints (as outlined above) to compare if any statistically significant difference is present. Statistical significance will be considered if a threshold of p=0.05. One-way repeated measures analysis of variance (ANOVA) will be performed for both groups.
Further sub-group analysis to determine correlations between the exploratory variables and outcomes will be performed using multi-linear and binary logistic regression. Standard demographical analysis will be collected and further sub-group analysis based on ethnicity may be performed.
Ethical approval has been obtained from the Health Research Authority.
This study is sponsored by Barts Health NHS Trust.
There are no conflicts of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment group | – | –Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy (e.g. biologic or small molecule) |
| Surgical treatment group | – | –Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults (>16) with a diagnosis of inflammatory bowel disease (IBD) attending a tertiary IBD centre who are undergoing a new treatment or change in treatment, or an operation for their condition
Key inclusion criteria (4 listed)
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery
- Age >16
- Patients able and willing to provide written informed consent
Key exclusion criteria (4 listed)
- Patients below the age of 16
- Patients who cannot provide informed consent
- Patients with a cardiac pacemaker or internal defibrillator
- Patients with active cancer and other disorders associated with severe cachexia
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
Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).
Time frame: 14 and 52 weeks
Clinical outcomes are as follows clinical response, clinical and biochemical remission, corticosteroid use, therapy switch or IBD related-surgery. Clinical response in UC is defined as a ≥2-point and ≥30% decrease from baseline in partial Mayo score and a ≥1-point decrease from baseline in rectal bleeding sub-score or an absolute rectal bleeding sub-score ≤1. Clinical response in CD is defined as ≥ 3 points decrease of HBI score. Clinical remission is defined as a partial Mayo score of 0-1 in UC or HBI of ≤4 in CD. Biochemical remission is defined as faecal calprotectin <200μg/mg and CRP ≤5mg/L.
Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing IBD-related surgery (at 30 and 90 days).
Time frame: 30 and 90 days
Clinical outcomes are defined as length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate.
2 secondary outcomes
Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).
Time frame: 14 and 52 weeks
Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced IBD-related surgery (at 30 and 90 days).
Time frame: 30 and 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 31648971GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.
- Background: PubMed 29562277Knowles SR, Graff LA, Wilding H, Hewitt C, Keefer L, Mikocka-Walus A. Quality of Life in Inflammatory Bowel Disease: A Systematic Review and Meta-analyses-Part I. Inflamm Bowel Dis. 2018 Mar 19;24(4):742-751. doi: 10.1093/ibd/izx100.
- Background: PubMed 21088749Lewis RT, Maron DJ. Efficacy and complications of surgery for Crohn's disease. Gastroenterol Hepatol (N Y). 2010 Sep;6(9):587-96.
- Background: PubMed 29118554Gklavas A, Dellaportas D, Papaconstantinou I. Risk factors for postoperative recurrence of Crohn's disease with emphasis on surgical predictors. Ann Gastroenterol. 2017;30(6):598-612. doi: 10.20524/aog.2017.0195. Epub 2017 Sep 26.
- Background: PubMed 29087396Ma C, Moran GW, Benchimol EI, Targownik LE, Heitman SJ, Hubbard JN, Seow CH, Novak KL, Ghosh S, Panaccione R, Kaplan GG. Surgical Rates for Crohn's Disease are Decreasing: A Population-Based Time Trend Analysis and Validation Study. Am J Gastroenterol. 2017 Dec;112(12):1840-1848. doi: 10.1038/ajg.2017.394. Epub 2017 Oct 31.
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- 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.
Shameer Mehta, MD principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 4 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Faloon, MBChB (07713444631, sarah.faloon@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks). (time frame: 14 and 52 weeks). The study lists 2 primary outcomes in all. 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 NCT06550310, which also lists 15 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 Feb 2026.