Clinical trial NCT04143139: Ileostomy Observation Study
Official title: Assessment of Bone Mineral Density, Vitamin D Status and Calcium Intakes in Ileostomy Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ileostomy - Stoma
Keywords: Bone mineral density
Ileostomists
Vitamin D
Observational study
Calcium
Phytochemical
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University of Naples
First posted: 2019-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ileostomy patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bone Density
timeFrame: 1 day, 1 measurement
Secondary outcomes:
measure: Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)
timeFrame: 1 day, 1 measurement
measure: Parathyroid hormone concentrations commercial kit)
timeFrame: 1 day, 1 measurement
measure: Serum adjusted calcium
timeFrame: 1 day, 1 measurement
measure: Lipid profile
timeFrame: 1 day, 1 measurement
measure: Plasma glucose
timeFrame: 1 day, 1 measurement
measure: Dietary intake,
timeFrame: 1 day, 1 measurement
measure: Phytochemical concentrations (plasma and ileal fluid) analysis
timeFrame: 1 day, 1 measurement
measure: Quality of life (QoL) questionnaire
timeFrame: 1 day, 1 measurement
measure: Heath and well being questionnaire
timeFrame: 1 day, 1 measurement
measure: Recent Physical Activity Questionnaire (RPAQ)
timeFrame: 1 day, 1 measurement
measure: Dietary component (plasma and ileal fluid) concentrations such as polyunsaturated fatty acids, endocannabinoids
timeFrame: 1 day, 1 measurement
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Co.Londonderry
Study officials:
References:
citation: Tagliamonte S, Gill CIR, Pourshahidi LK, Slevin MM, Price RK, Ferracane R, Lawther R, O'Connor G, Vitaglione P. Endocannabinoids, endocannabinoid-like molecules and their precursors in human small intestinal lumen and plasma: does diet affect them? Eur J Nutr. 2021 Jun;60(4):2203-2215. doi: 10.1007/s00394-020-02398-8. Epub 2020 Oct 26.