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The effect of branched-chain amino acid granules to innate immunity in decompensated cirrhosis, A randomized controlled trial

The effect of branched-chain amino acid granules to innate immunity in decompensated cirrhosis, A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190830005
Enrollment
72
Registered
2019-08-30
Start date
2019-10-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Decompensated cirrhosis&#44

Interventions

BCAAs granules (LIVACT®&#44
Ajinomoto pharmaceuticals CO.&#44
LTD.&#44
Japan
registration number: 2C 44/59&#44
ATC number: A16AA000101). The intervention groups will take 1 sachet after each meal (total of 3 sachets per day) during the study for 6 months. Each packet (4.15 g) of LIVACT® Granules contains the
Isoleucine 952 mg&#44
L&#45
Leucine 1904 mg and L&#45
Valine 1144 mg.,The identical placebo with equivalent calories given to control groups will be provided by EA. Pharma Co.&#44
Ltd. The control group will take 1 sachet after each meal (total of 3 sachets per day) for the study period of 6 months. Each packet contains 15 kilocalories (Fat 0 gm&#44
Cholesterol 0 gm&#44
protein 0 gm&#44
carbohydrate 2 gm&#44
and Na 10 mg)
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Branched&#45
chain amino acid granules,Controlled group

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor
EA Pharma Co.&#44
Collaborator
Ltd.
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Age between 18 to 70 years old. - Diagnosed with cirrhosis either by imaging or histopathology - Child-Pugh score ≥ 7 points - History or currently documented ascites by imaging - Agree to sign inform consent

Exclusion criteria

Exclusion criteria: &#45; Previous hospitalization due to infection within 3 months &#45; Any active malignancies &#45; life expectancy < 9 months &#45; Stop alcohol drinking < 6 months &#45; On steroid or Immunosuppressive drugs &#45; Uncontrolled diabetes mellitus defined by HbA1c ≥ 8 % &#45; HIV infection &#45; eGFR < 30 ml/min/1.73m2 &#45; History of taking branched&#45;chain amino acid &#45; Pregnancy or lactation &#45; MELD score ≥ 20 points

Design outcomes

Primary

MeasureTime frame
the efficacy of branched&#45;chain amino acid granules to restore innate immunity in term of phagocytosi 6 months Phagocytosis function percentage determine by flow cytometry after taking BCAA granules for 6 months—

Secondary

MeasureTime frame
The clinical outcomes of branched&#45;chain amino acid granules in infection incidence and 6 months Infection incidence and hospitalization due to infection during investigation period.,The Durable effect to phagocytosis of BCAA granules after stop treatment for 3 months 9 months Phagocytosis capacity percentage determine by flow cytometry after stop taking BCAA granules—

Countries

Thailand

Contacts

Public ContactNatthapat Rujeerapaiboon

Department of Internal Medicine&#44; Songklanagarind hospital

natthapat.ruj@gmail.com0896633623

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026