Short Chain Fatty Acids Concentration in Breast Milk Clinical Trial
Official title:
Short Chain Fatty Acids in Breast Milk
The purpose of this study is to determine whether the acetate, butyrate and propionate concentration in breast milk and to evaluate the possible correlation of these concentrations with maternal diet.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | May 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples. Exclusion Criteria: - infections, - diabetes and other chronic diseases at the level of each organ or system, - diseases of pregnancy. - antibiotics, prebiotics, probiotics and synbiotics in the 30 days prior to the first observation. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | "Federico II" University of Naples | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| Federico II University |
Italy,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | butyrate, acetate and propionate concentration | 10 days after delivery and every 30 days until the fifth month after delivery | No | |
| Secondary | Relationship between short chain fatty acids in breast milk and maternal diet (amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration) | Relationship between short chain fatty acids in breast milk and maternal diet will be measured by assessing the amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration. These assessments will be carried out by using a food diary carefully compiled by mothers before each sampling of breast milk | 10 days after delivery and every 30 days until the fifth month after delivery | No |