Ileostomy Observation Study

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04143139
• Other study ID #: 16/NI/0267
• Status: Enrolling by invitation
• Start date: July 10, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: June 2020
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ileostomy - Stoma

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	University of Naples

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Density	Dual Energy X-ray Absorptiometry (DXA)	1 day, 1 measurement
Secondary	Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)	Liquid Chromatography / Mass Spec (LC/MS)	1 day, 1 measurement
Secondary	Parathyroid hormone concentrations commercial kit)	Commercial kit	1 day, 1 measurement
Secondary	Serum adjusted calcium	Commercial kit	1 day, 1 measurement
Secondary	Lipid profile	Commercial kit	1 day, 1 measurement
Secondary	Plasma glucose	Commercial kit	1 day, 1 measurement
Secondary	Dietary intake,	Food dairy and Vitamin D Food Frequency Questionaire	1 day, 1 measurement
Secondary	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
Secondary	Quality of life (QoL) questionnaire	Coloplast Stoma-QoL; 20 questions, 4-point scale. Higher value representing higher QoL	1 day, 1 measurement
Secondary	Heath and well being questionnaire	SF36v2, Higher value representing a greater health and well-being status.	1 day, 1 measurement
Secondary	Recent Physical Activity Questionnaire (RPAQ)	Validated questionnaire measuring time spent in active and sedentary behaviour.	1 day, 1 measurement
Secondary	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