NCT04143139

Ileostomy Observation Study

Status unknown Last updated 18 June 2020

What this trial tests

trial in Ileostomy - Stoma in 200 participants. Status unknown.

Timeline

10 July 2017

Primary endpoint
1 October 2020

1 October 2020

Quick facts

Lead sponsor	University of Ulster
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	10 July 2017
Primary completion	1 October 2020
Estimated completion	1 October 2020
Sites	1 location across United Kingdom

Conditions studied

• Ileostomy - Stoma — all drugs for Ileostomy - Stoma →

Sponsor

University of Ulster

Who can join

Adults 18 to 70, any sex, with Ileostomy - Stoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Endocannabinoids, endocannabinoid-like molecules and their precursors in human small intestinal lumen and plasma: does diet affect them?
   Tagliamonte S, Gill CIR, Pourshahidi LK, Slevin MM, et al · · 2021 · cited 17× · PMID 33104865 · DOI 10.1007/s00394-020-02398-8