The effect of hydrolyzed collagen supplement alone or in combination with fish oil on gut microbiome in patients with burn

The effect of hydrolyzed collagen supplement alone or in combination with fish oil on gut microbiome in patients with burn

A randomized, double- blind , placebo- controlled , parallel design trial, with two intervention groups (collagen alone and collagen + fish oil) and a control group , stratified by Permuted Block Randomization

Patient selection from Motahhari Hospital considering the inclusion and exclusion criteria, randomized allocation of patients into 3 study groups, calculating calorie and daily protein intake for all patients individually, preparation and coding of supplements and placebo as A, B, and C by a person independent of the research, examination of anthropometric measurements and obtaining stool samples.

Inclusion Criteria: Burns of 20-45% of body surface area and degree 2 (deep) or 3 , 18-60years old men and women , the ability to oral intake up to 48 hours after admission Exclusion Criteria: Past medical history of diabetes and other endocrine disorders, cancer, digestive disorders and malabsorption , cardiovascular and respiratory diseases, organ failure such as liver and kidney failure , infectious disease , autoimmune disease , history of allergy or intolerance to protein, pregnant or postmenopausal women , smoking , addiction , alcohol consumption, taking NSAIDs and anticoagulant medications , taking high doses of protein or omega3 fatty acid supplements within 3 months prior to study.

1.Hydrolyzed collagen alone( 40 gr daily+ 9 ml sunflower oil) 2.Hydrolyzed collagen in combination with fish oil( 40 gr daily+ 9ml fish oil) 3.Placebo

Determination and comparison of gut Lactobacillus, Enterobacteriaceae, Bifidobacterium and firmicutes /bacteroidetes ratio between the 3 study groups.

For random allocation of individuals to the three groups, the permuted block randomization method will be applied, using a computer program, and the length of blocks will be considered randomly as 3, 6 or 9.

To blind both patients and investigators , the supplements and placebo will be given in combination with foods and will be similarly coded as A, B, and C. This process is done by one of the person independent of the study in the hospital.