The effects of Postbiotic in CVA patients

The effects of Postbiotic supplementation on Gut microbiota profiles and clinical factors in CVA patients under mechanical ventilation admitted to intensive care unit: a clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180712040438N7

Enrollment

Registered

2022-12-06

Start date

2022-12-21

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

stroke. Stroke, not specified as haemorrhage or infarction

Interventions

Intervention 1: Intervention group: Patients in the first group will be prescribed Lactobacillus paracasei postbiotic supplement (containing short-chain fatty acids and exopolysaccharides) in the amou

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with stroke and under mechanical ventilation admitted to the intensive care unit Age eighteen and older BMI= 18.5- 30 Written consent from relatives The patient has a tracheal tube and is under mechanical ventilation and it continues for 72 hours, and 48 hours have not passed since the patient's intubation and feeding should start within the next 24 hours.

Exclusion criteria

Exclusion criteria: pregnancy Weakening of the immune system for any reason receiving heart valve replacement vascular graft immune system suppressants

Design outcomes

Primary

Measure	Time frame
Duration of hospitalization in ICU. Timepoint: From the beginning of the study to the 28th day. Method of measurement: patient file.	—

Secondary

Measure	Time frame
Improving the composition of the intestinal microbiota. Timepoint: Before and after the intervention. Method of measurement: Via real time PCR.;BUN. Timepoint: At the time of patient admission, day 7, day 14 and day 28. Method of measurement: Enzymatic method.;Cr. Timepoint: At the time of patient admission, day 7, day 14 and day 28. Method of measurement: Enzymatic method.;Serum levels of hs-CRP. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Serum levels of ESR. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Serum levels of interleukin 6. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Serum levels of interleukin 10. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Improvement of nutritional status. Timepoint: NUTRIC scoring system. Method of measurement: At the beginning of admission and on the 28th day.;TAC. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;MDA. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Survival rate of patients in the ICU. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.;Duration of hospitalization. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.;Duration of intubation. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.;Mortality rate. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.	—

Measure

Time frame

Improving the composition of the intestinal microbiota. Timepoint: Before and after the intervention. Method of measurement: Via real time PCR.;BUN. Timepoint: At the time of patient admission, day 7, day 14 and day 28. Method of measurement: Enzymatic method.;Cr. Timepoint: At the time of patient admission, day 7, day 14 and day 28. Method of measurement: Enzymatic method.;Serum levels of hs-CRP. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Serum levels of ESR. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Serum levels of interleukin 6. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Serum levels of interleukin 10. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Improvement of nutritional status. Timepoint: NUTRIC scoring system. Method of measurement: At the beginning of admission and on the 28th day.;TAC. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;MDA. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA.;Survival rate of patients in the ICU. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.;Duration of hospitalization. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.;Duration of intubation. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.;Mortality rate. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactJalal Moludi

Kermanshah University of Medical Sciences

jmoludi@yahoo.com+98 83 3710 2003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026