Ileostomy - StomaNCT04143139
Ileostomy Observation Study
An observational study of Ileostomy - Stoma, run by University of Ulster at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2017to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ileostomy patients
Who may be able to join
- undergone an ileostomy and be more than 2 year post-operative
- non smoking
Who cannot join
- not undergone an ileostomy and/or is less than 2 year post-operative
- smoker.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Official title: Assessment of Bone Mineral Density, Vitamin D Status and Calcium Intakes in Ileostomy Patients.
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.
- Conditions
- Ileostomy - Stoma
- Keywords
- Bone mineral density, Ileostomists, Vitamin D, Observational study, Calcium, Phytochemical
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Density
Dual Energy X-ray Absorptiometry (DXA)
Measured: 1 day, 1 measurement
Secondary outcomes (11)
Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)
Liquid Chromatography / Mass Spec (LC/MS)
Measured: 1 day, 1 measurement
Parathyroid hormone concentrations commercial kit)
Commercial kit
Measured: 1 day, 1 measurement
Serum adjusted calcium
Commercial kit
Measured: 1 day, 1 measurement
Lipid profile
Commercial kit
Measured: 1 day, 1 measurement
Plasma glucose
Commercial kit
Measured: 1 day, 1 measurement
Dietary intake,
Food dairy and Vitamin D Food Frequency Questionaire
Measured: 1 day, 1 measurement
Phytochemical concentrations (plasma and ileal fluid) analysis
Gas Chromatography Mass Spect (GCMS) and Liquid Chromatography / Mass Spec (LC/MS) Mass Spec (LC/MS)
Measured: 1 day, 1 measurement
Quality of life (QoL) questionnaire
Coloplast Stoma-QoL; 20 questions, 4-point scale. Higher value representing higher QoL
Measured: 1 day, 1 measurement
Heath and well being questionnaire
SF36v2, Higher value representing a greater health and well-being status.
Measured: 1 day, 1 measurement
Recent Physical Activity Questionnaire (RPAQ)
Validated questionnaire measuring time spent in active and sedentary behaviour.
Measured: 1 day, 1 measurement
Dietary component (plasma and ileal fluid) concentrations such as polyunsaturated fatty acids, endocannabinoids
Gas Chromatography Mass Spect (GCMS) and Liquid Chromatography / Mass Spec
Measured: 1 day, 1 measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start10 Jul 2017
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Naples
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143139
- Sponsor's protocol ID
- 16/NI/0267
- Status last verified
- Jun 2020
- First submitted
- 7 Oct 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Mineral Density, Vitamin D Status and Calcium Intakes in Ileostomy Patients.
- ClinicalTrials.gov ID
- NCT04143139
- Acronym / sponsor ID
- 16/NI/0267
- Conditions
- Ileostomy - Stoma
- Keywords
- Bone mineral density, Ileostomists, Vitamin D, Observational study, Calcium, Phytochemical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Naples
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ileostomy patients
Key inclusion criteria (2 listed)
- undergone an ileostomy and be more than 2 year post-operative
- non smoking
Key exclusion criteria (2 listed)
- not undergone an ileostomy and/or is less than 2 year post-operative
- smoker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Density
Time frame: 1 day, 1 measurement
Dual Energy X-ray Absorptiometry (DXA)
11 secondary outcomes
Total serum 25-hydroxyvitamin D [25(OH)D] commercial kit)
Time frame: 1 day, 1 measurement
Parathyroid hormone concentrations commercial kit)
Time frame: 1 day, 1 measurement
Serum adjusted calcium
Time frame: 1 day, 1 measurement
Lipid profile
Time frame: 1 day, 1 measurement
Plasma glucose
Time frame: 1 day, 1 measurement
Dietary intake,
Time frame: 1 day, 1 measurement
Phytochemical concentrations (plasma and ileal fluid) analysis
Time frame: 1 day, 1 measurement
Quality of life (QoL) questionnaire
Time frame: 1 day, 1 measurement
Heath and well being questionnaire
Time frame: 1 day, 1 measurement
Recent Physical Activity Questionnaire (RPAQ)
Time frame: 1 day, 1 measurement
Dietary component (plasma and ileal fluid) concentrations such as polyunsaturated fatty acids, endocannabinoids
Time frame: 1 day, 1 measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 33104865Tagliamonte 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileostomy - Stoma, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Density (time frame: 1 day, 1 measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.