Ileostomy Observation Study

• Conditions: Ileostomy - Stoma

• Registration Number: NCT04143139
• Lead Sponsor: University of Ulster

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-10
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Density	1 day, 1 measurement	Dual Energy X-ray Absorptiometry (DXA)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Human Intervention Studies Unit, Ulster University; 🇬🇧 Coleraine, Co.Londonderry, United Kingdom