Trial Radar IA | ||
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Lo studio clinico NCT07297238 per Sindrome dell'intestino corto (SBS), Insufficienza intestinale è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration. 20 Randomizzato
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La sperimentazione clinica NCT07297238 è uno studio interventistico per Sindrome dell'intestino corto (SBS), Insufficienza intestinale, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 gennaio 2026, con l'obiettivo di raggiungere 20 partecipanti. Sotto la guida di Jinling Hospital, China, dovrebbe concludersi entro il 31 marzo 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 22 dicembre 2025.
Sommario breve
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...Mostra di più
Descrizione dettagliata
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 o...Mostra di più
Titolo ufficiale
Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial
Patologie
Sindrome dell'intestino corto (SBS)Insufficienza intestinalePubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- 2025-09-17
Numero NCT
Data di inizio (effettiva)
2026-01-01
Ultimo aggiornamento pubblicato
2025-12-22
Data di completamento (stimata)
2026-03-31
Arruolamento (previsto)
20
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
GLP-1
short bowel syndrome
intestinal failure
Intestinal Barrier Function
short bowel syndrome
intestinal failure
Intestinal Barrier Function
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleExperimental arm Participants received semaglutide as a subcutaneous injection (dosage form) at a dose of 0.25 mg (dosage) once weekly (frequency) for 28 days (duration). | GLP-1 Receptor Agonists 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. |
Nessun interventoControl arm received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy | N.D. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Serum Biomarkers of Intestinal Barrier Function | Serum Citrulline（µmol/L） | the initiation of enrollment and upon completion of the 28-days treatment period |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Intestinal absorption of nutrients (protein) | Intestinal nitrogen balance（Kjeldahl method for total nitrogen intake and excretion） | the initiation of enrollment and upon completion of the 28-days treatment period |
Intestinal absorption of nutrients (carbohydrate) | Fecal carbohydrate（Fecal pH measurement and analysis of fermentable substrates for indirect assessment） | the initiation of enrollment and upon completion of the 28-days treatment period |
Intestinal absorption of nutrients (fat) | Fat excretion rates（van de Kamer method for direct measurement of total fecal fat excretion） | the initiation of enrollment and upon completion of the 28-days treatment period |
Nutritional status indicator | Serum albumin (g/L) level | the initiation of enrollment and upon completion of the 28-days treatment period |
PN Liberation Rate | A 20% reduction in the weekly parenteral nutrition volume from baseline | the initiation of enrollment and upon completion of the 28-days treatment period |
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. | the initiation of enrollment and upon completion of the 28-days treatment period |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
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);
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.
- 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);
- 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.
Jinling Hospital, ChinaParte responsabile dello studio
Wang Xinying, Investigatore principale, Prof, Jinling Hospital, China
Contatti principali dello studio
Contatto: Xin Qi, MD, +86 18088680475, [email protected]
Contatto: Xinying Wang, MD, +86 13913028866, [email protected]
1 Centri dello studio in 1 paesi
China
Jinling Hospital, Nanning, China, 210002, China