Nanoselenium combined with glutamine versus glutamine alone for sepsis

ISRCTN	ISRCTN88007295
DOI	https://doi.org/10.1186/ISRCTN88007295
Sponsor	First Affiliated Hospital of Jinan University
Funder	Investigator initiated and funded

Submission date: 29/12/2025
Registration date: 06/01/2026
Last edited: 05/01/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Sepsis is a life-threatening organ dysfunction caused by infection, with high incidence and death rates, posing a significant global public health burden. Current treatments primarily rely on anti-inflammatory therapy and organ support, yet death rates remain high. Immunomodulation may emerge as a new therapeutic direction. Glutamine is an important energy source for immune cells, and selenium is a key trace element with antioxidant and immunomodulatory functions. This study aims to investigate the effects of nanoselenium combined with glutamine compared to glutamine alone on immune function, inflammatory response, organ function, intestinal mucosal barrier, and clinical outcomes in sepsis patients, with the goal of identifying a safer and more effective treatment strategy.

Who can participate?
Adult sepsis patients admitted to the ICU.

What does the study involve?
This is a single-center, randomized controlled trial. The plan is to recruit 120 eligible patients, randomly assigned into two groups of 60 each.
Control group: receives intravenous infusion of alanyl-glutamine injection alone (50 ml [10 g] alanyl-glutamine injection adding to 200 ml of 5% glucose), twice daily, for 7 days or until ICU discharge/death.
Intervention group: receives glutamine treatment as above, plus oral or nasogastric/nasointestinal administration of nanoselenium capsules (6 capsules/day, total selenium dose: 600 μg), once daily, for 7 days or until ICU discharge/death.
During the study, patient blood and urine samples will be collected to assess immune function, inflammatory markers, organ function, intestinal barrier function, selenium levels, and other relevant indicators. Clinical outcome data will also be recorded.

What are the possible benefits and risks of participating?
Possible benefits: Participants will receive standard sepsis treatment and close monitoring. The intervention treatment may help improve immune function and patient condition, although this effect is still under investigation.
Possible risks: Adverse reactions related to the study drugs (glutamine, nanoselenium) may occur, such as allergic reactions or abnormal liver function. The study will strictly monitor any adverse events and has a detailed risk management plan in place to ensure participant safety.

Where is the study run from?
The First Affiliated Hospital of Jinan University (China)

When is the study starting and how long is it expected to run for?
January 2026 to December 2027

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Wan-Jie Gu, guwanjie@jnu.edu.cn

Contact information

Prof Wan-Jie Gu
Principal investigator, Scientific, Public

613 Huangpu Avenue West
Guangzhou
510630
China

ORCID ID	0000-0003-4923-8282
Phone	+86 (0)15850546835
Email	guwanjie@jnu.edu.cn

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Supportive care, Treatment
Scientific title	Nanoselenium combined with glutamine versus Glutamine alone for Sepsis (NGS): a randomized controlled trial
Study acronym	NGS
Study objectives	The present study aims to evaluate the efficacy and safety of nanoselenium combined with glutamine versus glutamine alone in critically ill patients with sepsis, with particular focus on its effects on immune function, inflammatory markers, oxidative stress, organ function, intestinal barrier function, selenium levels, other relevant indicators, and clinical outcomes.
Ethics approval(s)	Approved 26/11/2025, Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University (613 Huangpu Avenue West, Guangzhou, 510630, China; +86 (0)20 38688077; haiyanyin1867@126.com), ref: KY-2025-308
Health condition(s) or problem(s) studied	Sepsis
Intervention	Eligible patients will be randomized to receive either the intervention or control in a 1:1 allocation ratio. The random allocation sequence will be generated by an independent statistician using computer software, with random block sizes of 4 and 6. To conceal the allocation, the assignments will be placed in sequentially numbered, opaque, sealed envelopes. The envelopes will be kept securely and opened only by the study coordinator after a participant is formally enrolled. To ensure blinding, the researchers administering the interventions, the patients and their families, the outcome assessors, and the data statisticians will all be kept unaware of the group assignments throughout the trial. Control group: receives intravenous infusion of alanyl-glutamine injection alone (50 ml [10 g] alanyl-glutamine injection adding to 200 ml of 5% glucose), twice daily, for 7 days or until ICU discharge/death. Intervention group: receives glutamine treatment as above, plus oral or nasogastric/nasointestinal administration of nanoselenium capsules (6 capsules/day, total selenium dose: 600μg), once daily, for 7 days or until ICU discharge/death.
Intervention type	Supplement
Primary outcome measure(s)	Immune function measured using total lymphocyte count, T lymphocyte count, Th lymphocyte (CD4) count, Ts lymphocyte (CD8) count, B lymphocyte count, NK lymphocyte count, immunoglobulins (IgG, IgA, IgM), and complements (C3, C4) at days 1, 4, 7, and 10 after randomization
Key secondary outcome measure(s)	Inflammatory markers measured using TNF-α, IL-2, IL-6, IL-10, IFN-γ, CRP, PCT, white blood cell count, neutrophil count, and serum amyloid protein at days 1, 4, 7, and 10 after randomization Organ function measured using oxygenation index (PaO2/FiO2), cardiac troponin (cTnI), serum creatinine, total bilirubin, platelet count, and lactate at days 1, 4, 7, and 10 after randomization Intestinal barrier function measured using D-lactate and zonulin at days 1, 4, 7, and 10 after randomization ICU and in-hospital mortality measured using the proportion of enrolled patients who die during ICU stay or hospital stay at until ICU/hospital discharge ICU and hospital length of stay measured using the total time from ICU/hospital admission to discharge at until ICU/hospital discharge/death Duration of mechanical ventilation measured using the accumulated time with invasive mechanical ventilatory support at until ICU discharge/death Selenium levels measured using blood and urine samples at days 1, 4, 7, and 10 after randomization
Completion date	31/12/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	120
Total final enrolment	120
Key inclusion criteria	1. Age ≥18 years old 2. Sepsis (as defined by Sepsis-3) 3. Expected to be admitted to the ICU for more than 48 hours
Key exclusion criteria	1. Refusal to participate or failure to provide informed consent 2. Pregnancy or breastfeeding 3. Known allergy to selenium or glutamine 4. Malignancy 5. Severe hepatic or renal dysfunction (including liver failure or dialysis-dependent uremia) 6. Receipt of immunosuppressive therapy or organ transplantation within the past 6 months 7. Fasting
Date of first enrolment	15/01/2026
Date of final enrolment	15/12/2027

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

29/12/2025: Study's existence confirmed by the Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University.