Glucagon-like peptide-1 as a treatment for chemotherapy-induced mucositis.
Hannelouise Kissow, Bolette Hartmann, Jens Juul Holst...
https://pubmed.ncbi.nlm.nih.gov/23086829Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07297238
Therapeutic Effect of GLP-1 (Semaglutide) on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure
Led by Jinling Hospital, China · Updated on 2026-05-28
20
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the effects of GLP-1 receptor agonists on intestinal barrier function in patients with short bowel syndrome and intestinal failure (SBS-IF). Participants are adults aged 18 to 80 years with confirmed SBS-IF receiving parenteral nutrition due to surgical resection of the small intestine. The study compares a group receiving semaglutide, a GLP-1 analog, alongside standard care to a control group receiving placebo plus standard care. The trial is randomized and single-blinded to assess treatment impact. Participants in the GLP-1 group receive subcutaneous injections of semaglutide at a dose of 0.25 mg once weekly for 28 days, following the manufacturer's instructions. The control group receives an appearance-matched placebo alongside standard care without additional GLP-1 intervention. The treatment period is strictly 28 days, with outcomes measured before and after this treatment phase. Throughout the study, participants undergo assessments including serum biomarkers of intestinal barrier function, nutrient absorption (protein, carbohydrate, fat), nutritional status indicators, parenteral nutrition liberation rate, and quality of life scores. These measures are collected at enrollment and after completing the 28-day treatment. The trial monitors participant health and adherence closely, aiming to evaluate the therapeutic effects of GLP-1 on intestinal health in this population.
CONDITIONS
Brief Title
Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Participants voluntarily provided written informed consent for this trial
- Aged 18 to 80 years, inclusive, regardless of gender
- Stable vital signs
- Diagnosis of short bowel syndrome and intestinal failure confirmed by medical or surgical records
- Receiving parenteral nutrition due to surgical resection of less than 200 cm of small intestine from the duodenojejunal flexure
- Colon continuity maintained without jejunal/ileal stoma (Type II or III) or presence of jejunostomy or ileostomy (Type I)
- Expected parenteral nutrition requirement for more than 4 weeks with average caloric intake of 80% or more
- Ability to comply with medication dosing and visit schedule
- Ability to accurately describe symptoms and absence of severe infections or respiratory insufficiency
- No history of allergic diseases or hypersensitivity to semaglutide injection components
- No history of drug abuse
- Not pregnant or lactating and no pregnancy plans within one month after the trial
- No participation in other drug trials within three months prior to enrollment
You will not qualify if you...
- Not meeting inclusion criteria or deemed ineligible by investigator
- Poor general condition or inability to accurately describe symptoms
- Severe infection or respiratory insufficiency
- History of allergic diseases, allergic constitution, or hypersensitivity to drugs related to the investigational product
- Presence of malignancy at any site
- Psychiatric disorders, inability to cooperate, or impaired consciousness
- Contraindications to the investigational drug, including personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Immunodeficiency or current use of immunosuppressants or corticosteroids
- Immediate family members of sponsor, investigator, or study staff involved in the trial
- Any other condition considered grounds for exclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 28 days
Participants receive weekly subcutaneous injections of semaglutide or placebo alongside standard care to assess the effect on intestinal barrier function.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 2 locations
1
Jinling Hospital
Nanjing, China, China, 210002
Actively Recruiting
2
Jinling Hospital
Nanning, China, China, 210002
Actively Recruiting
Loading map...
Research Team
X
Xin Qi, MD
X
Xinying Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
GLP-1 Induces Barrier Protective Expression in Brunner's Glands and Regulates Colonic Inflammation.
Claus H Bang-Berthelsen, Thomas L Holm, Charles Pyke...
https://pubmed.ncbi.nlm.nih.gov/27542128Liraglutide attenuates intestinal ischemia/reperfusion injury via NF-κB and PI3K/Akt pathways in mice.
Zhimiao Zou, Zhiheng Wang
https://pubmed.ncbi.nlm.nih.gov/36206837The Glucagon-Like Peptide 1 Receptor Agonist Exenatide Inhibits Small Intestinal Motility, Flow, Transit, and Absorption of Glucose in Healthy Subjects and Patients With Type 2 Diabetes: A Randomized Controlled Trial.
Sony S Thazhath, Chinmay S Marathe, Tongzhi Wu...
https://pubmed.ncbi.nlm.nih.gov/26470783Acute effects of continuous infusions of glucagon-like peptide (GLP)-1, GLP-2 and the combination (GLP-1+GLP-2) on intestinal absorption in short bowel syndrome (SBS) patients. A placebo-controlled study.
K B Madsen, C Askov-Hansen, R M Naimi...
https://pubmed.ncbi.nlm.nih.gov/23511332Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study.
Mark Hvistendahl, Christopher Filtenborg Brandt, Siri Tribler...
https://pubmed.ncbi.nlm.nih.gov/27875281ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults.
Loris Pironi, Jann Arends, Janet Baxter...
https://pubmed.ncbi.nlm.nih.gov/25311444Glycaemic variability and its association with enteral and parenteral nutrition in critically ill ventilated patients.
Ra'eesa Doola, Ristan M Greer, Rod Hurford...
https://pubmed.ncbi.nlm.nih.gov/30170779Hypoglycemia in noncritically ill patients receiving total parenteral nutrition: a multicenter study. (Study group on the problem of hyperglycemia in parenteral nutrition; Nutrition area of the Spanish Society of Endocrinology and Nutrition).
Gabriel Olveira, María José Tapia, Julia Ocón...
https://pubmed.ncbi.nlm.nih.gov/25441588Homeostasis alteration within small intestinal mucosa after acute enteral refeeding in total parenteral nutrition mouse model.
Yongjia Feng, Meredith Barrett, Yue Hou...
https://pubmed.ncbi.nlm.nih.gov/26635320