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Multi center clinical intervention study of HMB combined with Lactobacillus plantarum p-8 to accelerate the late rehabilitation of ICU-AW patients

Multi center clinical intervention study of HMB combined with Lactobacillus plantarum p-8 to accelerate the late rehabilitation of ICU-AW patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040738
Enrollment
Unknown
Registered
2020-12-08
Start date
2020-12-31
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU acquired weakness

Interventions

control:diet consult
intervention :Diet consult + HMB 3g / D (feeding in 3 times) + Lactobacillus plantarum p-8 2 pieces / day (containing 30 billion active probiotics in total)

Sponsors

The General Hospital of Western Command Theater of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) During the ICU in-hospital saty, the diagnosis of ICU-AW was clear, and the ICU was transferred to the rehabilitation department of the research institution for further observation and treatment; (2) Aged between 18 and 65 years old; (3) the planned hospitalization period was more than 3 months, and continuous follow-up was conducted after discharge; (4) voluntary participation in the study.

Exclusion criteria

Exclusion criteria: (1) There are various bone metabolism or muscle diseases, such as myasthenia gravis; (2) accompanied with tumor or type I diabetes, ckd4-5 stage of basic diseases, and severe liver disease; (3) family members of patients refused to participate in the study; (4) unable to eat by mouth or tube feeding; (5) accompanied by intestinal diseases affecting digestion, absorption, metabolism or excretion; or Factors; (6) accompanied by thyroid dysfunction or endocrine or metabolic diseases; (7) pregnant or lactating women; (8) history of mental illness; (9) previous history of allergy to drugs known to be used; (10) previous diarrhea, constipation, or intestinal inflammation; (11) use of probiotics, prebiotics and synbiotics two weeks before enrollment; (12) use of antibiotics Interruption or intestinal fungal infection.

Design outcomes

Primary

MeasureTime frame
Skeletal muscle mass of limbs (BIA method);MRC scoring;Intestinal flora (Bifidobacterium / Enterobacter Kobe value);

Secondary

MeasureTime frame
albumin;pre-albumin;globulin;Retinol binding protein,;transferrin;blood creatinine;TNF-ALFA;IL-1;IL-6;CRP;Urea nitrogen;endogenous creatinine clearance rate;daily average blood glucose;Quality of life;ALT;AST;

Countries

China

Contacts

Public ContactFu-xiang Li, Ning Lin

The General Hospital of Western Command Theater of PLA

525845176@qq.com+86 13980074996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026