CClinicalTrials.gg
Status unknownNCT04143139Updated Jun 18, 2020

Ileostomy Observation Study

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

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ileostomy - Stoma

Keywords

  • Bone mineral density
  • Ileostomists
  • Vitamin D
  • Observational study
  • Calcium
  • Phytochemical
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Ileostomy patients

Inclusion criteria

  • undergone an ileostomy and be more than 2 year post-operative
  • non smoking

Exclusion criteria

Exclusion Criteria:

  • not undergone an ileostomy and/or is less than 2 year post-operative
  • smoker.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Bone Density

    Dual Energy X-ray Absorptiometry (DXA)

    Time frame: 1 day, 1 measurement

Secondary outcomes

  1. Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)

    Liquid Chromatography / Mass Spec (LC/MS)

    Time frame: 1 day, 1 measurement

  2. Parathyroid hormone concentrations commercial kit)

    Commercial kit

    Time frame: 1 day, 1 measurement

  3. Serum adjusted calcium

    Commercial kit

    Time frame: 1 day, 1 measurement

  4. Lipid profile

    Commercial kit

    Time frame: 1 day, 1 measurement

  5. Plasma glucose

    Commercial kit

    Time frame: 1 day, 1 measurement

  6. Dietary intake,

    Food dairy and Vitamin D Food Frequency Questionaire

    Time frame: 1 day, 1 measurement

  7. 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

  8. Quality of life (QoL) questionnaire

    Coloplast Stoma-QoL; 20 questions, 4-point scale. Higher value representing higher QoL

    Time frame: 1 day, 1 measurement

  9. Heath and well being questionnaire

    SF36v2, Higher value representing a greater health and well-being status.

    Time frame: 1 day, 1 measurement

  10. Recent Physical Activity Questionnaire (RPAQ)

    Validated questionnaire measuring time spent in active and sedentary behaviour.

    Time frame: 1 day, 1 measurement

  11. 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

07

Study locations

1 site
  • Human Intervention Studies Unit, Ulster University
    Coleraine, Co.Londonderry BT52 1SA, United Kingdom
08

References and documents

Publications

  • 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. PubMed 33104865 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04143139
Lead sponsor
University of Ulster
Collaborators
University of Naples
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Jul 10, 2017
Primary completion
Oct 1, 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Jun 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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