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Bovine colostrum and acute respiratory failure

"The effect of enteral bovine colostrum supplement on outcomes of critically ill patients with acute respiratory failure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220425054648N1
Enrollment
90
Registered
2022-06-24
Start date
2022-07-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Respiratory Failure. Respiratory failure, unspecified

Interventions

Intervention 1: Control group: Patients in this group receive 20 grams of enteral high protein formula (Karen Pharma & Food Supplement, Co., Tehran, Iran) once a day for a minimum of 5 days and a maxi

Sponsors

National Nutrition & Food Technology Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with acute respiratory failure Completion of informed consent form by the patient or legal guardian Feeding by enteral nutrition 18-65 years old Body Mass Index less than 35 kg/m2

Exclusion criteria

Exclusion criteria: No metastatic cancer or end stage disease Lack of intolerance to milk (lactose) Don't participate in other clinical trial studies at the same time as the present study

Design outcomes

Primary

MeasureTime frame
Incidence of nosocomial infection. Timepoint: The incidence of nosocomial infection is assessed up to 3 days after discharge from the hospital. Method of measurement: The incidence of nosocomial infection is based on the results of laboratory tests and medical records.

Secondary

MeasureTime frame
The Mean concentration of serum CD markers (CD4, CD8). Timepoint: The CD markers (CD4, CD8) variable are measured at the beginning and end of the intervention. Method of measurement: Evaluation of CD marker variables (CD4, CD8) are performed using ELISA method and related kits.;The Mean concentration of serum Insulin-like Growth Factor1. Timepoint: The Insulin-like Growth Factor1 variable is measured at the beginning and end of the intervention. Method of measurement: Evaluation of Insulin-like Growth Factor1 is performed using ELISA method and related kits.;Duration of hospitalization in the hospital, duration of hospitalization in the intensive care unit. Timepoint: The evaluation of these variables is from the beginning of the intervention to the time of hospitalization of the patient in the hospital and intensive care unit. Method of measurement: The evaluation of these variables is based on the information recorded in the patients' hospital records.;Patient mortality rate in hospital and intensive care unit. Timepoint: The evaluation of these variables is from the beginning of the intervention to the time of possible death of the patient in the hospital and intensive care unit. Method of measurement: The evaluation of these variables is based on the information recorded in the patients' hospital records.;Gastrointestinal complications (diarrhea, constipation, nausea, abdominal distension). Timepoint: Evaluation of these variables is from the beginning of the intervention to the end of the intervention. Method of measurement: Based on reports recorded in the patient's file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Rouhelhami

Shahid Beheshti University of Medical Sciences

elham.roohelhami@gmail.com+98 21 2207 7425

Outcome results

None listed

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