|- candidate number||3910|
|- NTR Number||NTR1427|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-sep-2008|
|- Secondary IDs||IRCT010707 |
|- Public Title||The microflora in milk from mothers and the gastro-intestinal tract of their infants. |
|- Scientific Title||Influence of probiotic consumption by breast feeding mothers on microbes in mothers milk and the fecal infant micoflora.|
|- hypothesis||The administration of probiotics to breastfeeding females exert a direct influence on the development of the infant gut microflora through the transference of selected strains.|
|- Healt Condition(s) or Problem(s) studied||Breastfeeding , Gut health, Biomarkers, Microflora|
|- Inclusion criteria||1. Mother/child pair of which the mother delivered through natural birth. |
2. Mother/child pair of which the infant is breast fed for at least 6 weeks.
3. Mothers and children without any clinical aberrancy.
|- Exclusion criteria||1. Mother/child pair with formula fed children.|
2. Mother/child pair of which the child was delivered through cesarian section.
3. Mothers consuming probiotics preparations/drinks/etc. other then supplied in the studie.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2007|
|- planned closingdate||1-aug-2009|
|- Target number of participants||60|
|- Interventions||A group of healthy lactating women will consume a capsule of probiotics and a group of healthy lactating women will consume a placebo. The reference group will receive no supplementation at all during 6 weeks. |
1. Study intervention
- Nutrition: the probiotic product is the commercially available FERROSAN probiotic powder.
- The different intervention groups
A) Reference: 30 breastfeeding mother/child pairs.
B) Placebo: 10 breastfeeding mothers consuming placebo (powder dissolved in boiling milk, consumed after cooling)
C) Treatment: 10 breastfeeding mothers consuming probiotic powder supplemented milk.
A) Mothers Breastmilk (5-10 ml) at 4 and 6 weeks of study
B) Infant fecal samples (ca. 5g) after receiving 4 and 6 weeks of breastfeeding (at least 75%) and 2, 4 and 6 weeks in case of the reference group.
|- Primary outcome||- Effect of probiotic consumption of a breast feeding mother on the fecal microflora composition of the child|
- Relation microflora of mothermilk and microflora of breastfed infants
|- Secondary outcome||- pH of fecal samples|
- Immunoglobulins in fecal samples and breast milk
|- Timepoints||2, 4, 6 weeks after birth|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Biesebeke, te|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Biesebeke, te|
|- Sponsor/Initiator ||Friesland Foods|
(Source(s) of Monetary or Material Support)
|- Publications||Effect of consumption of Probiotics by Breastfeeding Mothers on the Fecal Microflora of Infants.|
|- Brief summary||The indigenous microflora appears to be especially relevant in infants that develop a microflora balance in the lumen of the GI-tract during first months of life. Next to improvement of the mucosal barrier function, the microflora population in the GI-tract is enhanced by the generation of immunophysiologic regulation in the gut. |
This has led to the introduction of novel therapeutic interventions based on the consumption of cultures of beneficial live microorganisms that act as probiotics.
There seems to be some preliminary evidence that oral and/or gut bacteria can enter the uterine environment suggesting that the gastrointestinal tract not only functions as a barrier against antigens from microorganisms and food but that the barrier is also involved in the selective passage of micro-organisms to the blood.
Although highly speculative, this would mean that the administration of probiotics to pregnant females might exert a direct influence on the development of the infant gut microflora through the transference of selected strains to neonates. In addition, breast milk has been suggested as an important factor in the initiation, development and composition of the neonatal gut microflora. Up to date several scientific papers have suggested that breastmilk might be the source of commensal and/or potential probiotic bacteria, since bacteria commonly isolated from breastmilk include staphylococci, streptococci, micrococci, lactobacilli and enterococci.
|- Main changes (audit trail)|
|- RECORD||3-sep-2008 - 16-sep-2008|