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Short Bowel Syndrome (SBS)NCT07297238

Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.

A study testing GLP-1 Receptor Agonists in people with Short Bowel Syndrome (SBS) and Intestinal Failure, run by Jinling Hospital, China at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Eligible patients were randomized into two groups: the GLP-1 group and the control group. The control group received a placebo along with standard care, without any additional GLP-1-based intervention. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
GLP-1 Receptor Agonists
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
24 Jan 2026to 30 Jun 2026
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants voluntarily provided written informed consent for this trial;
  • Aged 18 to 80 years, inclusive, regardless of gender;
  • With stable vital signs;
  • Diagnosis of SBS-IF, confirmed by existing medical/surgical records, receiving parenteral nutrition (PN) due to surgical resection of the small intestine (<200 cm from the duodenojejunal flexure), and meeting one of the following criteria:
  • Colon continuity maintained without jejunal/ileal stoma (Type II or III);
  • Presence of a jejunostomy or ileostomy (Type I);
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  • Expected requirement of PN for more than 4 weeks, with an average PN caloric intake ≥80%;
  • Ability to comply with the medication dosing and visit schedule;
  • Capacity to accurately describe symptoms, absence of severe infections or respiratory insufficiency, and willingness to cooperate proactively;
  • No history of allergic diseases, non-allergic constitution, and no hypersensitivity to any component of semaglutide injection;
  • No history of drug abuse;
  • Not pregnant or lactating; no pregnancy plans within one month after the trial (applies to both female and male participants);
  • No participation in any other drug trials (including the investigational product in this study) within three months prior to enrollment.

Who cannot join

  • Individuals who do not meet the inclusion criteria or are deemed ineligible by the investigator;
  • Poor general condition, inability to accurately describe symptoms, presence of severe infection, respiratory insufficiency, or other conditions that may hinder active cooperation;
  • History of allergic diseases, allergic constitution, or hypersensitivity to drugs structurally related to the investigational product;
  • Patients with malignancy at any site;
  • Those with psychiatric disorders, inability to cooperate, or impaired consciousness;
  • Patients with contraindications to the investigational drug (including personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2);
Show all 9Show fewer
  • Immunodeficiency, or current use of immunosuppressants or corticosteroids;
  • Immediate family members of the sponsor, investigator, or study staff directly involved in the trial;
  • Any other condition considered by the investigator as grounds for exclusion.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Jinling Hospital

    Nanjing, China, 210002

  • Jinling Hospital

    Nanning, China, 210002

Other trials in China

About this study

Official title: Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial

Eligible patients were randomized into two groups: the GLP-1 group and the control group. The control group received a placebo along with standard care, without any additional GLP-1-based intervention. The GLP-1 group, in addition to standard care, received a subcutaneous injection of a GLP-1 analog (semaglutide injection) strictly according to the drug manufacturer's instructions. The initial dose of semaglutide was 0.25 mg once weekly. Treatment was continued over a 28-days period. Primary and secondary outcomes will be collected.

Read the detailed description

Eligible patients with short bowel syndrome and intestinal failure were randomly assigned to one of two groups: the GLP-1 group or the control group. The control group received a placebo along with standard care. The GLP-1 group, in addition to standard care, was administered a GLP-1 analog (semaglutide injection) via subcutaneous injection strictly according to the manufacturer's instructions, with an initial dose of semaglutide of 0.25 mg once weekly. Primary and secondary outcomes will be collected.

Being tested
GLP-1 Receptor Agonists
Keywords
GLP-1, short bowel syndrome, intestinal failure, Intestinal Barrier Function
Medical subject headings
Short Bowel Syndrome, Intestinal Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLP-1 Receptor AgonistsDrug

    Also called GLP-1RAs

    GLP-1 receptor agonists (semaglutide) are medications that mimic the action of the native human hormone glucagon-like peptide-1 (GLP-1). The recommended dosage is 0.25 mg administered subcutaneously once weekly.

Study groups in NCT07297238
Study groupRoleWhat they receive
Experimental armExperimentalParticipants received semaglutide as a subcutaneous injection (dosage form) at a dose of 0.25 mg (dosage) once weekly (frequency) for 28 days (duration).
Receives: Drug: GLP-1 Receptor Agonists
Control armNo interventionreceived appearance-matched placebo plus standard care, no additional semaglutide intervention therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Biomarkers of Intestinal Barrier Function

    Serum Citrulline（µmol/L）

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

Secondary outcomes (6)

  1. Intestinal absorption of nutrients (protein)

    Intestinal nitrogen balance（Kjeldahl method for total nitrogen intake and excretion）

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

  2. Intestinal absorption of nutrients (carbohydrate)

    Fecal carbohydrate（Fecal pH measurement and analysis of fermentable substrates for indirect assessment）

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

  3. Intestinal absorption of nutrients (fat)

    Fat excretion rates（van de Kamer method for direct measurement of total fecal fat excretion）

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

  4. Nutritional status indicator

    Serum albumin (g/L) level

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

  5. PN Liberation Rate

    A 20% reduction in the weekly parenteral nutrition volume from baseline

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

  6. Quality of life score

    Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 4-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life.

    Measured: the initiation of enrollment and upon completion of the 28-days treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start24 Jan 2026
  3. Primary completion27 May 2026
  4. Study completion30 Jun 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07297238
Sponsor's protocol ID
2025-09-17
Status last verified
Jul 2026
First submitted
19 Sep 2025
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kissow H, Hartmann B, Holst JJ, Poulsen SS. Glucagon-like peptide-1 as a treatment for chemotherapy-induced mucositis. Gut. 2013 Dec;62(12):1724-33. doi: 10.1136/gutjnl-2012-303280. Epub 2012 Oct 20.

    PubMed 23086829

  • Bang-Berthelsen CH, Holm TL, Pyke C, Simonsen L, Sokilde R, Pociot F, Heller RS, Folkersen L, Kvist PH, Jackerott M, Fleckner J, Vilien M, Knudsen LB, Heding A, Frederiksen KS. GLP-1 Induces Barrier Protective Expression in Brunner's Glands and Regulates Colonic Inflammation. Inflamm Bowel Dis. 2016 Sep;22(9):2078-97. doi: 10.1097/MIB.0000000000000847.

    PubMed 27542128

  • Zou Z, Wang Z. Liraglutide attenuates intestinal ischemia/reperfusion injury via NF-kappaB and PI3K/Akt pathways in mice. Life Sci. 2022 Nov 15;309:121045. doi: 10.1016/j.lfs.2022.121045. Epub 2022 Oct 4.

    PubMed 36206837

  • Thazhath SS, Marathe CS, Wu T, Chang J, Khoo J, Kuo P, Checklin HL, Bound MJ, Rigda RS, Crouch B, Jones KL, Horowitz M, Rayner CK. The 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. Diabetes. 2016 Jan;65(1):269-75. doi: 10.2337/db15-0893. Epub 2015 Oct 15.

    PubMed 26470783

  • Madsen KB, Askov-Hansen C, Naimi RM, Brandt CF, Hartmann B, Holst JJ, Mortensen PB, Jeppesen PB. Acute 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. Regul Pept. 2013 Jun 10;184:30-9. doi: 10.1016/j.regpep.2013.03.025. Epub 2013 Mar 16.

    PubMed 23511332

  • Hvistendahl M, Brandt CF, Tribler S, Naimi RM, Hartmann B, Holst JJ, Rehfeld JF, Hornum M, Andersen JR, Henriksen BM, Brobech Mortensen P, Jeppesen PB. Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):112-121. doi: 10.1177/0148607116672265. Epub 2017 Dec 11.

    PubMed 27875281

  • Pironi L, Arends J, Baxter J, Bozzetti F, Pelaez RB, Cuerda C, Forbes A, Gabe S, Gillanders L, Holst M, Jeppesen PB, Joly F, Kelly D, Klek S, Irtun O, Olde Damink SW, Panisic M, Rasmussen HH, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM, Shaffer J; Home Artificial Nutrition & Chronic Intestinal Failure; Acute Intestinal Failure Special Interest Groups of ESPEN. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults. Clin Nutr. 2015 Apr;34(2):171-80. doi: 10.1016/j.clnu.2014.08.017. Epub 2014 Sep 21.

    PubMed 25311444

  • Doola R, Greer RM, Hurford R, Flatley C, Forbes JM, Todd AS, Joyce CJ, Sturgess DJ. Glycaemic variability and its association with enteral and parenteral nutrition in critically ill ventilated patients. Clin Nutr. 2019 Aug;38(4):1707-1712. doi: 10.1016/j.clnu.2018.08.001. Epub 2018 Aug 16.

    PubMed 30170779

  • Olveira G, Tapia MJ, Ocon J, Cabrejas-Gomez C, Ballesteros-Pomar MD, Vidal-Casariego A, Arraiza-Irigoyen C, Olivares J, Conde-Garcia MC, Garcia-Manzanares A, Botella-Romero F, Quilez-Toboso RP, Matia P, Rubio MA, Chicharro L, Burgos R, Pujante P, Ferrer M, Zugasti A, Petrina E, Manjon L, Dieguez M, Carrera MJ, Vila-Bundo A, Urgeles JR, Aragon-Valera C, Sanchez-Vilar O, Breton I, Garcia-Peris P, Munoz-Garach A, Marquez E, Del Olmo D, Pereira JL, Tous MC. Hypoglycemia 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). Nutrition. 2015 Jan;31(1):58-63. doi: 10.1016/j.nut.2014.04.023. Epub 2014 May 10.

    PubMed 25441588

  • Feng Y, Barrett M, Hou Y, Yoon HK, Ochi T, Teitelbaum DH. Homeostasis alteration within small intestinal mucosa after acute enteral refeeding in total parenteral nutrition mouse model. Am J Physiol Gastrointest Liver Physiol. 2016 Feb 15;310(4):G273-84. doi: 10.1152/ajpgi.00335.2015. Epub 2015 Dec 3.

    PubMed 26635320

  • Pironi L, Steiger E, Joly F, Jeppesen PB, Wanten G, Sasdelli AS, Chambrier C, Aimasso U, Mundi MS, Szczepanek K, Jukes A, Theilla M, Kunecki M, Daniels J, Serlie M, Poullenot F, Cooper SC, Rasmussen HH, Compher C, Seguy D, Crivelli A, Santarpia L, Guglielmi FW, Kozjek NR, Schneider SM, Ellegard L, Thibault R, Matras P, Matysiak K, Van Gossum A, Forbes A, Wyer N, Taus M, Virgili NM, O'Callaghan M, Chapman B, Osland E, Cuerda C, Udvarhelyi G, Jones L, Won Lee AD, Masconale L, Orlandoni P, Spaggiari C, Diez MB, Doitchinova-Simeonova M, Serralde-Zuniga AE, Olveira G, Krznaric Z, Czako L, Kekstas G, Sanz-Paris A, Jauregui MEP, Murillo AZ, Schafer E, Arends J, Suarez-Llanos JP, Youssef NN, Brillanti G, Nardi E, Lal S; Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN; European Society for Clinical Nutrition and Metabolism. Characteristics of adult patients with chronic intestinal failure due to short bowel syndrome: An international multicenter survey. Clin Nutr ESPEN. 2021 Oct;45:433-441. doi: 10.1016/j.clnesp.2021.07.004. Epub 2021 Jul 28.

    PubMed 34620351

  • Derenski K, Catlin J, Allen L. Parenteral Nutrition Basics for the Clinician Caring for the Adult Patient. Nutr Clin Pract. 2016 Oct;31(5):578-95. doi: 10.1177/0884533616657650. Epub 2016 Jul 20.

    PubMed 27440772

  • Pironi L, Cuerda C, Jeppesen PB, Joly F, Jonkers C, Krznaric Z, Lal S, Lamprecht G, Lichota M, Mundi MS, Schneider SM, Szczepanek K, Van Gossum A, Wanten G, Wheatley C, Weimann A. ESPEN guideline on chronic intestinal failure in adults - Update 2023. Clin Nutr. 2023 Oct;42(10):1940-2021. doi: 10.1016/j.clnu.2023.07.019. Epub 2023 Jul 29.

    PubMed 37639741

  • Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Muhlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN practical guideline: Home parenteral nutrition. Clin Nutr. 2023 Mar;42(3):411-430. doi: 10.1016/j.clnu.2022.12.003. Epub 2023 Jan 9.

    PubMed 36796121

Questions about this trial

What is this clinical trial studying?

A study testing GLP-1 Receptor Agonists in people with Short Bowel Syndrome (SBS) and Intestinal Failure, run by Jinling Hospital, China at 2 sites in China.

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 13 inclusion and 9 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Serum Biomarkers of Intestinal Barrier Function (time frame: the initiation of enrollment and upon completion of the 28-days treatment period). 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 NCT07297238, which also lists 14 linked publications.

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 14 Jul 2026.

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