Short Bowel SyndromeNCT07235670
Gastrointestinal Hormone Secretion, Intestinal Permeability and Short Bowel Syndrome
A study testing Standardized meal in people with Short Bowel Syndrome and Intestinal Resection, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The gastrointestinal tract is a complex endocrine organ that regulates a wide range of physiological processes, including those involved in the digestion of nutrients. These processes are dynamically coordinated by specialized cells within the intestinal epithelium which, upon exposure to luminal nutrients, secrete a… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome, Intestinal Resection
- What is being tested?
- Standardized meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2021to 16 Jun 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having any history of resection of small intestine. Information regarding remnant bowel anatomy will be based on data obtained from patient medical records.
- At least 6 months since last intestinal resection.
- If diagnosed with liver cirrhosis, patients should score a maximum of 12 points on the Child-Pugh scoring system (corresponds to Child-Pugh C with a maximum of 12 points). Patients scoring more than 12 points are considered to have terminal cirrhosis and will be excluded from the study. It is likely that terminally cirrhotic patients have concurrent disease processes that could influence results.
- Age between 18 years and 80 years (both included)
- BMI between 16 and 30 (both included)
- Able to ingest a standardized meal containing 2841 kJ (679 kcal). The meal consisted of 21 g protein, 78 g carbohydrate, and 31 g fat, corresponding to a macronutrient distribution of 13% protein, 46% carbohydrate, and 41% fat. It included 50 g rye bread, 50 g coarse bread, 32 g butter, 40 g cheese (45+), 20 g jam, 150 g fruit yogurt, 100 g banana, and 200 g water
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- Healthy controls subjects:
- Not diagnosed with any chronic or acute disease
- BMI between 16 and 30 (both included)
- Negative pregnancy test (plasma hCG) for women of childbearing potential (at screening visit)
- Age between 18 years and 80 years (both included)
- Able to ingest the meal presented in inclusion criteria no. 6.
Who cannot join
- Over hepatic encephalopathy.
- Cholangiocarcinoma.
- Hepatocellular carcinoma.
- Other known or suspected cancer.
- Radiation enteritis, gastrointestinal involvement of systemic scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue.
- eGFR <30 mL/min/1,73m2
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- Clinically meaningful renal disease as judged by the investigator.
- Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the study, or interfere with the analysis of the trial results.
- Positive pregnancy test (plasma hCG) for women of childbearing potential (at screening visit) or lactation.
- Planned to undergo an imminent liver transplantation or have undergone a liver transplantation.
- Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests.
- A history of clinically significant intestinal adhesions and/or chronic abdominal pain.
- History of gallstone within the past 3 years. Gallstones with subsequent cholecystectomy to resolve the issues are acceptable.
- Inflammatory bowel disease (IBD) patients who have NOT been on a stable drug treatment regimen for at least the past 4 weeks.
- Evidence of active IBD in the past 12 weeks.
- Visible blood in the stool within the last 3 months.
- Catheter-related sepsis experienced within the last month.
- Heart failure (New York Heart Association [NYHA] class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening.
- Unplanned hospitalisation of >24 hours duration within 1 month before the screening visit.
- Any use of growth hormone, glutamine or growth factors such as native glucagon-like peptide-2 (GLP-2) or GLP-1 analogues within the last 3 months.
- Any use of dipeptidyl peptidase-4 (DPP-IV) inhibitors within the last 3 months.
- Any use of antibiotics within the last 30 days (except for prophylactic treatment for urinary tract infections).
- Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening.
- Patient not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
- For any other reason judged not eligible by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Hormone Secretion, Bile Acid Homeostasis, Intestinal Permeability and Bacterial Translocation in Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Alcoholic Liver Cirrhosis and Short Bowel Syndrome (SBS)
The gastrointestinal tract is a complex endocrine organ that regulates a wide range of physiological processes, including those involved in the digestion of nutrients. These processes are dynamically coordinated by specialized cells within the intestinal epithelium which, upon exposure to luminal nutrients, secrete a variety of enteroendocrine hormones, such as Gastrin, Cholecystokinin, Glucose-dependent insulinotropic peptide, Neurotensin, Glucagon-like peptide 1, Glucagon-like peptide 2, and Peptide YY.
In this study, we aim to investigate how resection of different intestinal segments affects fasting and postprandial secretion of these gut hormones, and to characterize how these secretion profiles differ compared with healthy controls.
Read more
Patients with a history of intestinal resection will be included and stratified according to the intestinal segments in continuity at the time of study participation into the following anatomical groups:
- Group 1A: Patients with jejunum only in continuity and a total small bowel length <150 cm.
- Group 1B: Patients with an ileostomy and a maximum resection of 30 cm of the terminal ileum. The colon is not in continuity, and the ileocecal valve is also not in continuity.
- Group 2: Patients with <150 cm jejunum anastomosed to the ascending colon or proximally in the transverse colon.
- Group 3: Patients with a jejuno-ileal anastomosis, an intact ileocecal valve, and the entire colon in continuity.
In addition, healthy control subjects will be included to enable comparison between patient groups and normal physiology.
Fasting blood samples will be obtained after a standardized rest period, after which all participants will ingest a standardized meal within 15 minutes. Subsequently, repeated blood samples will be collected at t = 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes postprandially.
Differences between groups in fasting values, area-under-the-curve (AUC), and incremental AUC, values will be calculated. Differences between anatomical groups will be analyzed using analysis of variance (ANOVA) on log-transformed data to improve model fit. Correlations between the secretion profiles of different enteroendocrine hormones will be assessed using Pearson's r.
- Conditions
- Short Bowel Syndrome, Intestinal Resection
- Being tested
- Standardized meal
- Keywords
- Gastrin, CCK, GIP, Neurotensin, GLP-1, GLP-2, PYY, Intestinal resection
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized mealDietary supplement
A standardized meal containing 2841 kJ (679 kcal). The meal consisted of 21 g protein, 78 g carbohydrate, and 31 g fat, corresponding to a macronutrient distribution of 13% protein, 46% carbohydrate, and 41% fat. It included 50 g rye bread, 50 g coarse bread, 32 g butter, 40 g cheese (45+), 20 g jam, 150 g fruit yogurt, 100 g banana, and 200 g water
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Standardized meal Receives: Dietary Supplement: Standardized meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial levels of entero-endocrine hormones
Measured: 255 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jun 2021
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
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 Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palle Bekker Jeppesen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235670
- Sponsor's protocol ID
- H-17038155
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pinar I, Andersen JHM, Lund S, Rasmussen KK, Hvistendahl MK, Brandt CF, Hartmann B, Rehfeld JF, Holst JJ, Jeppesen PB. Impact of intestinal resections on the secretion of gastrointestinal hormones. Clin Nutr. 2026 Aug;63:106713. doi: 10.1016/j.clnu.2026.106713. Epub 2026 Jun 11.
PubMed 42320379
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Hormone Secretion, Bile Acid Homeostasis, Intestinal Permeability and Bacterial Translocation in Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Alcoholic Liver Cirrhosis and Short Bowel Syndrome (SBS)
- ClinicalTrials.gov ID
- NCT07235670
- Acronym / sponsor ID
- H-17038155
- Conditions
- Short Bowel Syndrome, Intestinal Resection
- Keywords
- Gastrin, CCK, GIP, Neurotensin, GLP-1, GLP-2, PYY, Intestinal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 19 Nov 2025 (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.
The gastrointestinal tract is a complex endocrine organ that regulates a wide range of physiological processes, including those involved in the digestion of nutrients. These processes are dynamically coordinated by specialized cells within the intestinal epithelium which, upon exposure to luminal nutrients, secrete a variety of enteroendocrine hormones, such as Gastrin, Cholecystokinin, Glucose-dependent insulinotropic peptide, Neurotensin, Glucagon-like peptide 1, Glucagon-like peptide 2, and Peptide YY.
In this study, we aim to investigate how resection of different intestinal segments affects fasting and postprandial secretion of these gut hormones, and to characterize how these secretion profiles differ compared with healthy controls.
Patients with a history of intestinal resection will be included and stratified according to the intestinal segments in continuity at the time of study participation into the following anatomical groups:
- Group 1A: Patients with jejunum only in continuity and a total small bowel length <150 cm.
- Group 1B: Patients with an ileostomy and a maximum resection of 30 cm of the terminal ileum. The colon is not in continuity, and the ileocecal valve is also not in continuity.
- Group 2: Patients with <150 cm jejunum anastomosed to the ascending colon or proximally in the transverse colon.
- Group 3: Patients with a jejuno-ileal anastomosis, an intact ileocecal valve, and the entire colon in continuity.
In addition, healthy control subjects will be included to enable comparison between patient groups and normal physiology.
Fasting blood samples will be obtained after a standardized rest period, after which all participants will ingest a standardized meal within 15 minutes. Subsequently, repeated blood samples will be collected at t = 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes postprandially.
Differences between groups in fasting values, area-under-the-curve (AUC), and incremental AUC, values will be calculated. Differences between anatomical groups will be analyzed using analysis of variance (ANOVA) on log-transformed data to improve model fit. Correlations between the secretion profiles of different enteroendocrine hormones will be assessed using Pearson's r.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Dietary Supplement: Standardized mealStandardized meal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Having any history of resection of small intestine. Information regarding remnant bowel anatomy will be based on data obtained from patient medical records.
- At least 6 months since last intestinal resection.
- If diagnosed with liver cirrhosis, patients should score a maximum of 12 points on the Child-Pugh scoring system (corresponds to Child-Pugh C with a maximum of 12 points). Patients scoring more than 12 points are considered to have terminal cirrhosis and will be excluded from the study. It is likely that terminally cirrhotic patients have concurrent disease processes that could influence results.
- Age between 18 years and 80 years (both included)
- BMI between 16 and 30 (both included)
Key exclusion criteria (25 listed)
- Over hepatic encephalopathy.
- Cholangiocarcinoma.
- Hepatocellular carcinoma.
- Other known or suspected cancer.
- Radiation enteritis, gastrointestinal involvement of systemic scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized mealA standardized meal containing 2841 kJ (679 kcal). The meal consisted of 21 g protein, 78 g carbohydrate, and 31 g fat, corresponding to a macronutrient distribution of 13% protein, 46% carbohydrate, and 41% fat. It included 50 g rye bread, 50 g coarse bread, 32 g butter, 40 g cheese (45+), 20 g jam, 150 g fruit yogurt, 100 g banana, and 200 g water | Dietary supplement | Single-arm |
Primary outcome
Fasting and postprandial levels of entero-endocrine hormones
Time frame: 255 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 42320379Pinar I, Andersen JHM, Lund S, Rasmussen KK, Hvistendahl MK, Brandt CF, Hartmann B, Rehfeld JF, Holst JJ, Jeppesen PB. Impact of intestinal resections on the secretion of gastrointestinal hormones. Clin Nutr. 2026 Aug;63:106713. doi: 10.1016/j.clnu.2026.106713. Epub 2026 Jun 11.
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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?
A study testing Standardized meal in people with Short Bowel Syndrome and Intestinal Resection, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 12 inclusion and 25 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: finished, as of the sponsor's last update on 19 Nov 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fasting and postprandial levels of entero-endocrine hormones (time frame: 255 minutes). 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 NCT07235670, 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 19 Nov 2025.