Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJinling Hospital, China
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants voluntarily provided written informed consent for this trial;
Aged 18 to 80 years, inclusive, regardless of gender;
With stable vital signs;
Colon continuity maintained without jejunal/ileal stoma (Type II or III);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
GLP-1 Receptor Agonists
DrugGLP-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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Experimental armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Serum Biomarkers of Intestinal Barrier Function
Serum Citrulline（µmol/L）
Time frame
the initiation of enrollment and upon completion of the 28-days treatment periodSecondary outcomes
1
Intestinal absorption of nutrients (protein)
Intestinal nitrogen balance（Kjeldahl method for total nitrogen intake and excretion）
Time frame
the initiation of enrollment and upon completion of the 28-days treatment period2
Intestinal absorption of nutrients (carbohydrate)
Fecal carbohydrate（Fecal pH measurement and analysis of fermentable substrates for indirect assessment）
Time frame
the initiation of enrollment and upon completion of the 28-days treatment period3
Intestinal absorption of nutrients (fat)
Fat excretion rates（van de Kamer method for direct measurement of total fecal fat excretion）
Time frame
the initiation of enrollment and upon completion of the 28-days treatment period4
Nutritional status indicator
Serum albumin (g/L) level
Time frame
the initiation of enrollment and upon completion of the 28-days treatment periodSponsors and contacts
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Source ClinicalTrials.gov