NCT07235670

Gastrointestinal Hormone Secretion, Intestinal Permeability and Short Bowel Syndrome

Completed NA Last updated 19 November 2025

What this trial tests

NA trial testing Standardized meal in Short Bowel Syndrome in 39 participants. Completed in 16 June 2022.

Timeline

1 June 2021

Primary endpoint
16 June 2022

16 June 2022

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	39
Start date	1 June 2021
Primary completion	16 June 2022
Estimated completion	16 June 2022
Sites	1 location across Denmark

Drugs / interventions tested

• Standardized meal

Conditions studied

• Short Bowel Syndrome — all drugs for Short Bowel Syndrome →
• Intestinal Resection — all drugs for Intestinal Resection →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 18 to 80, any sex, with Short Bowel Syndrome or Intestinal Resection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.