Short Chain Fatty Acids Concentration in Breast MilkNCT02301728
Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet
An observational study of Short Chain Fatty Acids Concentration in Breast Milk, run by Federico II University at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Short Chain Fatty Acids Concentration in Breast Milk
- What is being tested?
- sampling of breast milk, obtaining information about the maternal diet
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.
Who may be able to join
- parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
"Federico II" University of Naples
Naples, Naples, 80131
Annalisa Passariello, MD, PhD, + 39 081 746 2680, annalisa.passariello@unina.it
roberto berni canani, MD, PhD, + 39 081 746 2680, berni@unina.it
About this study
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.
- Being tested
- sampling of breast milk, obtaining information about the maternal diet
- Keywords
- breast milk, short chain fatty acids, maternal diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling of breast milk, obtaining information about the maternal dietOther
take samples of 3 ml breast milk and 3-days diet diaries
What is being measured
The primary outcome is the main question the study is designed to answer.
butyrate, acetate and propionate concentration
Measured: 10 days after delivery and every 30 days until the fifth month after delivery
Secondary outcomes (1)
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
Measured: 10 days after delivery and every 30 days until the fifth month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Short Chain Fatty Acids Concentration in Breast MilkStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Passariello, Federico II University
- Investigators
- Annalisa Passariello, MD, PhD, Principal investigator, "Federico II" University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301728
- Sponsor's protocol ID
- BMB-100
- Status last verified
- Nov 2014
- First submitted
- 15 Nov 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
Publications
Topping DL, Clifton PM. Short-chain fatty acids and human colonic function: roles of resistant starch and nonstarch polysaccharides. Physiol Rev. 2001 Jul;81(3):1031-64. doi: 10.1152/physrev.2001.81.3.1031.
PubMed 11427691Macfarlane S, Macfarlane GT. Regulation of short-chain fatty acid production. Proc Nutr Soc. 2003 Feb;62(1):67-72. doi: 10.1079/PNS2002207.
PubMed 12740060Resta-Lenert S, Truong F, Barrett KE, Eckmann L. Inhibition of epithelial chloride secretion by butyrate: role of reduced adenylyl cyclase expression and activity. Am J Physiol Cell Physiol. 2001 Dec;281(6):C1837-49. doi: 10.1152/ajpcell.2001.281.6.C1837.
PubMed 11698242Roediger WE. Role of anaerobic bacteria in the metabolic welfare of the colonic mucosa in man. Gut. 1980 Sep;21(9):793-8. doi: 10.1136/gut.21.9.793.
PubMed 7429343Kunzelmann K, Mall M. Electrolyte transport in the mammalian colon: mechanisms and implications for disease. Physiol Rev. 2002 Jan;82(1):245-89. doi: 10.1152/physrev.00026.2001.
PubMed 11773614Binder HJ, Mehta P. Short-chain fatty acids stimulate active sodium and chloride absorption in vitro in the rat distal colon. Gastroenterology. 1989 Apr;96(4):989-96. doi: 10.1016/0016-5085(89)91614-4.
PubMed 2925072Boffa LC, Gruss RJ, Allfrey VG. Manifold effects of sodium butyrate on nuclear function. Selective and reversible inhibition of phosphorylation of histones H1 and H2A and impaired methylation of lysine and arginine residues in nuclear protein fractions. J Biol Chem. 1981 Sep 25;256(18):9612-21.
PubMed 6270094Belderbos ME, Houben ML, van Bleek GM, Schuijff L, van Uden NO, Bloemen-Carlier EM, Kimpen JL, Eijkemans MJ, Rovers M, Bont LJ. Breastfeeding modulates neonatal innate immune responses: a prospective birth cohort study. Pediatr Allergy Immunol. 2012 Feb;23(1):65-74. doi: 10.1111/j.1399-3038.2011.01230.x. Epub 2011 Nov 22.
PubMed 22103307
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Chain Fatty Acids in Breast Milk
- ClinicalTrials.gov ID
- NCT02301728
- Acronym / sponsor ID
- BMB-100
- Keywords
- breast milk, short chain fatty acids, maternal diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.
Key inclusion criteria (1 listed)
- parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling of breast milk, obtaining information about the maternal diettake samples of 3 ml breast milk and 3-days diet diaries | Other | – |
Primary outcome
butyrate, acetate and propionate concentration
Time frame: 10 days after delivery and every 30 days until the fifth month after delivery
1 secondary outcome
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)
Time frame: 10 days after delivery and every 30 days until the fifth month after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Background: PubMed 11427691Topping DL, Clifton PM. Short-chain fatty acids and human colonic function: roles of resistant starch and nonstarch polysaccharides. Physiol Rev. 2001 Jul;81(3):1031-64. doi: 10.1152/physrev.2001.81.3.1031.
- Background: PubMed 12740060Macfarlane S, Macfarlane GT. Regulation of short-chain fatty acid production. Proc Nutr Soc. 2003 Feb;62(1):67-72. doi: 10.1079/PNS2002207.
- Background: PubMed 11698242Resta-Lenert S, Truong F, Barrett KE, Eckmann L. Inhibition of epithelial chloride secretion by butyrate: role of reduced adenylyl cyclase expression and activity. Am J Physiol Cell Physiol. 2001 Dec;281(6):C1837-49. doi: 10.1152/ajpcell.2001.281.6.C1837.
- Background: PubMed 7429343Roediger WE. Role of anaerobic bacteria in the metabolic welfare of the colonic mucosa in man. Gut. 1980 Sep;21(9):793-8. doi: 10.1136/gut.21.9.793.
- Background: PubMed 11773614Kunzelmann K, Mall M. Electrolyte transport in the mammalian colon: mechanisms and implications for disease. Physiol Rev. 2002 Jan;82(1):245-89. doi: 10.1152/physrev.00026.2001.
- Background: PubMed 2925072Binder HJ, Mehta P. Short-chain fatty acids stimulate active sodium and chloride absorption in vitro in the rat distal colon. Gastroenterology. 1989 Apr;96(4):989-96. doi: 10.1016/0016-5085(89)91614-4.
- Background: PubMed 6270094Boffa LC, Gruss RJ, Allfrey VG. Manifold effects of sodium butyrate on nuclear function. Selective and reversible inhibition of phosphorylation of histones H1 and H2A and impaired methylation of lysine and arginine residues in nuclear protein fractions. J Biol Chem. 1981 Sep 25;256(18):9612-21.
- Background: PubMed 22103307Belderbos ME, Houben ML, van Bleek GM, Schuijff L, van Uden NO, Bloemen-Carlier EM, Kimpen JL, Eijkemans MJ, Rovers M, Bont LJ. Breastfeeding modulates neonatal innate immune responses: a prospective birth cohort study. Pediatr Allergy Immunol. 2012 Feb;23(1):65-74. doi: 10.1111/j.1399-3038.2011.01230.x. Epub 2011 Nov 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annalisa Passariello, MD, PhD principal investigator
"Federico II" University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Chain Fatty Acids Concentration in Breast Milk, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Passariello, MD, PhD (+ 39 081 746 2680, annalisa.passariello@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
butyrate, acetate and propionate concentration (time frame: 10 days after delivery and every 30 days until the fifth month after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301728, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.