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Effect of probiotic on management of critically ill patients

Effect of probiotic containing lactobacillus, bifidobacterium and streptococus thermophilus administration on inflammatory, coagulation and oxidative factors in critically ill patients with risk of sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112143320N6
Enrollment
40
Registered
2011-12-29
Start date
2011-12-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

sepsis. Sepsis, unspecified

Interventions

Intervention 1: 2 Sachets of probiotic VSL 3 (containing lactobacillus, bifidobacterium and streptococus species)/day for 7 days. Intervention 2: 2 sachet of placebo/day for 7 days.
Treatment - Drugs
Placebo
2 Sachets of probiotic VSL 3 (containing lactobacillus, bifidobacterium and streptococus species)/day for 7 days
2 sachet of placebo/day for 7 days

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) critically ill patients admitted to the surgical ICU with positive SIRS and APACHE II score 15 to 30; 2) receiving enteral nutrition; 3) aging 18-40 years old; 4) expected to stay in ICU for at least 7 days. Exclusion criteria: 1) pregnant and lactating women; 2) patients who cannot tolerate enteral nutrition; 3) unstable hemodynamic; 4) smoking; 5) immune disorders and diabetes mellitus; 6) intestinal obstruction; 7) intestinal ischemia; 8) Patients who are expected to expire in the next 24 hours; 9) HIV-positive; 10) cancer; 11) bedsore; 12) bone marrow, liver or lung transplantation; 13) short bowel syndrome, pancreatitis and kidney or liver failure; 14) receiving Lactulose, mannitol, and glutamine during the study; 15) patients undergoing GI procedures (endoscopy, resection of the bowel and GI surgeries) during the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Inflammation. Timepoint: days 1, 4, 7. Method of measurement: IL6, PCT.;Coagulation. Timepoint: days 1, 4, 7. Method of measurement: protein C.;Oxidative stress. Timepoint: days 1, 4, 7. Method of measurement: TAC, MDA.

Secondary

MeasureTime frame
Mortality. Timepoint: days 1, 4, 7. Method of measurement: being live or dead.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSarvin Sanaie

Tabriz University of Medical Sciences

sarvin.sanaie@gmail.com+98 41 1335 7580

Outcome results

None listed

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