Ileostomy Observation Study

Study Overview
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Brief Summary
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Inflammatory bowel disease (IBD) which is associated with low bone mineral density is divided into 2 major disease entities: Crohn's disease and ulcerative colitis. Medical therapy is directed at controlling symptoms and reducing the underlying inflammatory process. Studies have reported that 60% of patients with Crohn's disease and 15%-30% of patients with ulcerative colitis require surgical intervention for the management of their disease. In the United Kingdom almost 13,000 ileostomy procedures are undertaken annually. A 29.4% prevalence of low bone mineral density (BMD) was reported in a cohort of US patients with IBD and ileostomy who were >5 years postoperative. Possible risk factors for bone loss in patients with IBD and ileostomy are considered to include malabsorption secondary to bowel resection, malnutrition and more aggressive disease and inflammation which led to bowel resection in the first place . These factors also contribute to reduced intestinal absorption of nutrients and vitamins including B & D subsequently leading to potential health complications including low BMI and low lean body mass. It has been reported that IBD patients who have surgical intervention to create ileal pouches also have low levels of vitamin D. Surgical procedures such as an ileostomy alter the normal anatomy and physiology of the small intestine. Bile acid (BA) malabsorption which is common to IBD is caused by impaired conjugated BA reabsorption and a consequence, numerous pathological sequelae may occur, including the malfunction of lipid digestion . Further, bacterial overgrowth can lead to deconjugation of bile salts, leading to formation of free bile acids, again inducing dietary fat malabsorption, which in turn can lead to vitamin D deficiency. As vitamin D is a fat-soluble vitamin, malfunction of lipid digestion or absorption is problematic. Given the paucity of data in the area of ileostomy patients BMD, vitamin D status and calcium intake, we will establish baseline observations within the Northern Ireland (NI) population with an observational study to assess bone mineral density (Dexa), collecting ileal fluid and plasma samples assessing vitamin D status, calcium, dietary intake and other measures including questionnaires on quality of life and exercise.

Official Title
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Assessment of Bone Mineral Density, Vitamin D Status and Calcium Intakes in Ileostomy Patients.

Conditions
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Ileostomy - Stoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergone an ileostomy and be more than 2 year post-operative non smoking Exclusion Criteria: not undergone an ileostomy and/or is less than 2 year post-operative smoker.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Density | Dual Energy X-ray Absorptiometry (DXA) | 1 day, 1 measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit) | Liquid Chromatography / Mass Spec (LC/MS) | 1 day, 1 measurement | 
| Parathyroid hormone concentrations commercial kit) | Commercial kit | 1 day, 1 measurement | 
| Serum adjusted calcium | Commercial kit | 1 day, 1 measurement | 
| Lipid profile | Commercial kit | 1 day, 1 measurement | 
| Plasma glucose | Commercial kit | 1 day, 1 measurement | 
| Dietary intake, | Food dairy and Vitamin D Food Frequency Questionaire | 1 day, 1 measurement | 
| Phytochemical concentrations (plasma and ileal fluid) analysis | Gas Chromatography Mass Spect (GCMS) and Liquid Chromatography / Mass Spec (LC/MS) Mass Spec (LC/MS) | 1 day, 1 measurement | 
| Quality of life (QoL) questionnaire | Coloplast Stoma-QoL; 20 questions, 4-point scale. Higher value representing higher QoL | 1 day, 1 measurement | 
| Heath and well being questionnaire | SF36v2, Higher value representing a greater health and well-being status. | 1 day, 1 measurement | 
| Recent Physical Activity Questionnaire (RPAQ) | Validated questionnaire measuring time spent in active and sedentary behaviour. | 1 day, 1 measurement | 
| Dietary component (plasma and ileal fluid) concentrations such as polyunsaturated fatty acids, endocannabinoids | Gas Chromatography Mass Spect (GCMS) and Liquid Chromatography / Mass Spec | 1 day, 1 measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone mineral density, Ileostomists, Vitamin D, Observational study, Calcium, Phytochemical