microbiota
Conditions
Interventions
The study was performed as a single-blind randomized placebo controlled trial. After
randomization, one group of lactating women (n = 28) received 20 sachets containing 4.5g of the prebiotic fructooli
Dietary supplement
G07.203.300.456
Sponsors
Universidade de São Paulo
Hospital Universitário da Universidade de Sâo Paulo
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 37 Years
Inclusion criteria
Inclusion criteria: Healthy lactating women having term babies (born between 37 and 42 weeks), with adequate weight for gestational age; having normal bowel frequency (minimum once every 2 days, maximum 3 times per day).
Exclusion criteria
Exclusion criteria: No chronic gastrointestinal disease; genetic disease; cardiac disease; kidney disease; hypertension; diabetes mellitus or immunodeficiency diseases; eclampsia or gestational diabetes during pregnancy; mastitis during the lactation period; have taken proton pump inhibitors; H2 receptor antagonists; antidepressants; narcotics; anticholinergic medications; laxatives, or anti-diarrhea medications within 30 days prior to collection the milk samples; regular consumption of commercially available, prebiotic- or probiotic supplemented product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: To evaluate differences in the diversity of bacterial groups naturally found in the human milk before and after the intervention with the prebiotic (fructooligosaccharides) or placebo (maltodextrin), by bacterial genetic sequencing, from finding statistically significant differences in the proportion of the bacterial groups before and after the intervention.;Found outcome 1: The diversity of bacterial groups naturally present in human milk before and after intervention with the prebiotic (fructo-oligosaccharide) or placebo (maltodextrin), verified by genetic sequencing of the bacteria, did not show statistically significant differences in the proportion of bacterial groups before and after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: to evaluate the bowel frequency of the participants who had received the prebiotic compared to the bowel frequency of the participants in the placebo group, by a questionnaire, from finding statistically significant differences in the bowel frequency of the participants in the groups.;Found outcome 1:the bowel frequency of the participants who had received the prebiotic compared to the bowel frequency of the participants in the placebo group, by a questionnaire, did not show statistically significant differences between the groups after the intervention. | — |
Countries
Brazil
Contacts
Public ContactMarina;Susana Padilha;Saad
Universidade de São Paulo;Universidade de São Paulo
Outcome results
None listed