An observational study in Ileostomy - Stoma, sponsored by University of Ulster. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by University of Ulster · Observational
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.
University of Ulster is the lead sponsor of 94 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ileostomy patients
Exclusion Criteria:
Bone Density
Dual Energy X-ray Absorptiometry (DXA)
Time frame: 1 day, 1 measurement
Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)
Liquid Chromatography / Mass Spec (LC/MS)
Time frame: 1 day, 1 measurement
Parathyroid hormone concentrations commercial kit)
Commercial kit
Time frame: 1 day, 1 measurement
Serum adjusted calcium
Commercial kit
Time frame: 1 day, 1 measurement
Lipid profile
Commercial kit
Time frame: 1 day, 1 measurement
Plasma glucose
Commercial kit
Time frame: 1 day, 1 measurement
Dietary intake,
Food dairy and Vitamin D Food Frequency Questionaire
Time frame: 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)
Time frame: 1 day, 1 measurement
Quality of life (QoL) questionnaire
Coloplast Stoma-QoL; 20 questions, 4-point scale. Higher value representing higher QoL
Time frame: 1 day, 1 measurement
Heath and well being questionnaire
SF36v2, Higher value representing a greater health and well-being status.
Time frame: 1 day, 1 measurement
Recent Physical Activity Questionnaire (RPAQ)
Validated questionnaire measuring time spent in active and sedentary behaviour.
Time frame: 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
Time frame: 1 day, 1 measurement
Plan to share: No
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Ulster