Growth hormone may cut IV feeding needs for short bowel patients
NCT ID NCT07691125
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This trial tests whether injections of recombinant human growth hormone can reduce the amount of intravenous (IV) nutrition needed by adults with short bowel syndrome. About 100 participants who rely on IV nutrition will receive the hormone for 4 weeks, and researchers will measure changes in their IV support volume. The goal is to see if this treatment can ease the burden of daily IV feeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human growth hormone injection
- What this could lead to
- If it works, this could reduce the amount of IV nutrition needed, making daily life easier for people with short bowel syndrome.
- What could go wrong
- This is a small, early-phase trial without a placebo group, so results may not be definitive. Growth hormone can have side effects like joint pain or fluid retention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or older, regardless of gender; 2. Diagnosed with Short Bowel Syndrome (SBS); 3. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the ULN; serum creatinine for renal function ≤ 1.5 times the ULN; 4. All female participants who are not postmenopausal (last menstrual period ≥ 12 months prior to the screening visit) and have not undergone hysterectomy (or bilateral salpingectomy) must agree to use one recognized highly effective contraceptive method from the date of signing the informed consent form until 1 month after the last Saizeng® treatment; 5. Male participants must use contraception, or their female partners shall satisfy any of the conditions specified in Item 5 above; 6. Able to voluntarily sign the informed consent form and willing to complete the trial in full compliance with the study protocol. Exclusion Criteria: 1. Subjects with a history of allergic reactions to the study drug or its analogues; subjects unsuitable for subcutaneous injection, including those receiving anticoagulant therapy, presenting with thrombocytopenia, known hemorrhagic diseases, or idiopathic thrombocytopenic purpura (ITP). 2. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA ≥ 1000 IU/mL within 6 months prior to screening; subjects with positive anti-HCV antibody and HCV RNA level exceeding the upper limit of normal (ULN) set by the study center. 3. Subjects with a prior diagnosis of malignant tumors before screening. 4. Subjects with consciousness disturbance, a history of psychiatric illness, or severe neurological dysfunction. 5. Subjects with glycated hemoglobin (HbA1c) ≥ 7% at screening. 6. Subjects with any of the following clinically significant cardiovascular disorders: * History of chronic congestive heart failure with New York Heart Association (NYHA) functional class ≥ II at screening; * Subjects who experienced myocardial infarction, acute coronary syndrome, viral myocarditis or pulmonary embolism within 6 months before screening, or underwent coronary revascularization within the preceding 6 months; * Severe arrhythmias requiring treatment with Class Ia or Class III antiarrhythmic agents; * Sick sinus syndrome, second-degree type II or third-degree atrioventricular block without an implanted pacemaker; * QTc interval ≥ 470 ms for male subjects or ≥ 480 ms for female subjects at screening (calculated via the Fridericia correction formula: QTc = QT/RR⁰·³³), or a medical history of prolonged QTc interval. 7. Subjects with uncontrolled hypertension: those receiving 1 to 2 oral antihypertensive drugs whose arterial blood pressure remains ≥ 160/100 mmHg on any two measurements taken within one day at screening. 8. Subjects suffering from diseases requiring daily systemic glucocorticoid therapy (prednisone ≥ 10 mg/day or equivalent doses of other glucocorticoids) or immunosuppressant therapy (e.g., active inflammatory bowel disease, autoimmune disorders, radiation enteritis), and continuous treatment is expected throughout the trial period; subjects who received systemic glucocorticoids cumulatively for ≥28 days or consecutively for ≥14 days within 3 months prior to screening. 9. Subjects who have received stem cell therapy, any form of bone marrow transplantation, or solid organ transplantation. 10. Subjects whose abdominal radiotherapy was completed less than 2 years before screening. 11. Subjects with positive serum human chorionic gonadotropin (HCG) at screening; breastfeeding women. 12. Subjects who have taken investigational medicinal products or participated in other clinical trials within 1 month prior to screening. 13. Participants judged by the investigator to be unsuitable for enrollment in this clinical trial based on their medical history.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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General Hospital of Eastern Theater Command
RECRUITINGNanjing, Jiangsu, 210002, China
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Zhongshan Hospital Affiliated to Xiamen University
RECRUITINGXiamen, Fujian, 361004, China