Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550310
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Nutrition and Clinical Outcomes in IBD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nutrition and Body Composition and Association With Clinical Outcomes in Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
2 To correlate nutritional status nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
3 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
The main objectives are
1 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
2 To correlate nutritional status nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
3 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 Crohns disease CD and ulcerative colitis UC It affects nearly 400000 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 CTMRI 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 CTMRI 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 CTMRI 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 p005 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
Inflammatory bowel disease IBD comprises Crohns disease CD and ulcerative colitis UC It affects nearly 400000 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 CTMRI 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 CTMRI 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 CTMRI 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 p005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None