رادار التجارب AI | ||
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حالة التجربة السريرية NCT07297238 لـ متلازمة الأمعاء القصيرة (SBS)، فشل الأمعاء هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration. ٢٠ عشوائية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT07297238 هي دراسة تدخُّلية لـمتلازمة الأمعاء القصيرة (SBS)، فشل الأمعاء وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٢ رجب ١٤٤٧ هـ لتجنيد ٢٠ مشاركًا. يقودها Jinling Hospital, China، ومن المتوقع اكتمالها بحلول ١٢ شوال ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢ رجب ١٤٤٧ هـ.
الملخص
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...عرض المزيد
وصف مفصل
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...عرض المزيد
العنوان الرسمي
Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial
الحالات الطبية
متلازمة الأمعاء القصيرة (SBS)فشل الأمعاءالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- 2025-09-17
NCT معرّف
تاريخ البدء (فعلي)
2026-01-01
آخر تحديث مُنشور
2025-12-22
تاريخ الاكتمال (المقدر)
2026-03-31
عدد المشاركين المخطط لهم
٢٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
GLP-1
short bowel syndrome
intestinal failure
Intestinal Barrier Function
short bowel syndrome
intestinal failure
Intestinal Barrier Function
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةExperimental 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. |
بدون تدخلControl arm received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Serum Biomarkers of Intestinal Barrier Function | Serum Citrulline（µmol/L） | the initiation of enrollment and upon completion of the 28-days treatment period |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
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, Chinaالجهة المسؤولة عن الدراسة
Wang Xinying, المحقق الرئيسي, Prof, Jinling Hospital, China
جهة اتصال مركزية للدراسة
جهة اتصال: Xin Qi, MD, +86 18088680475, [email protected]
جهة اتصال: Xinying Wang, MD, +86 13913028866, [email protected]
1 مواقع الدراسة في 1 بلدان
China
Jinling Hospital, Nanning, China, 210002, China