Critical Illness Clinical Trial
Official title:
Effects of Colostrum Supplement on Inflammatory and Growth Factors, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Verified date | November 2018 |
Source | National Nutrition and Food Technology Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 7, 2018 |
Est. primary completion date | November 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients (>18 years old) admitted to ICU - Start of study intervention within 48 hours after ICU admission - Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour - Written informed consent of patient or written informed consent of legal representative Exclusion Criteria: - Enrollment in a related ICU interventional study - Requiring other specific enteral nutrition for medical reason - Death or Discharge before 5th day - Having any contra-indication to receive enteral nutrition - Pregnant patients or lactating with the intent to breastfeed - BMI <18 or > 40.0 kg/m2 - Have life expectancy of <6 mo - Patients who are moribund - History of allergy or intolerance to the study product components - Receiving colostrum during two weeks before start study product - Have other reasons |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | National Nutrition and Food Technology Research Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
National Nutrition and Food Technology Institute |
Iran, Islamic Republic of,
Benson KF, Carter SG, Patterson KM, Patel D, Jensen GS. A novel extract from bovine colostrum whey supports anti-bacterial and anti-viral innate immune functions in vitro and in vivo: I. Enhanced immune activity in vitro translates to improved microbial clearance in animal infection models. Prev Med. 2012 May;54 Suppl:S116-23. doi: 10.1016/j.ypmed.2011.12.023. Epub 2011 Dec 28. — View Citation
Kim JW, Jeon WK, Kim EJ. Combined effects of bovine colostrum and glutamine in diclofenac-induced bacterial translocation in rat. Clin Nutr. 2005 Oct;24(5):785-93. — View Citation
Rathe M, Müller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of infection | Day 28 | ||
Secondary | 28-day Mortality | Day 28 | ||
Secondary | 6-month mortality | month 6 | ||
Secondary | Length of stay in ICU | Day 28 | ||
Secondary | Serum Immunity Markers | baseline, Day 5, Day 10 | ||
Secondary | Serum Inflammatory Markers | baseline, Day 5, Day 10 |
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