Prebiotic GOS and lactoferrin for beneficial gut microbiota with iron supplements (PREFER)
Not Applicable
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202009698591500
- Lead Sponsor
- ational Institute of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
(i) delivery vaginally or by cesarean section,
(ii) an infant age of 6 months (±3 weeks),
(iii) mother =15 years of age,
(iv) infant still breastfeeding, and
(v) anticipated residence in the area for the study duration.
Exclusion Criteria
(i) inability to provide informed consent,
(ii) hemoglobin < 70 g/L,
(iii) Z scores for weight-for-age (WAZ) or weight-for-height (WHZ) <3,
(iv) any maternal or infant chronic illness,
(v) administration of any vitamin or mineral supplements for the past 2 months, and
(vi) any history of antibiotic treatment in the past seven days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera at 1 month.
- Secondary Outcome Measures
Name Time Method The ratio of the abundances of potentially harmful to beneficial bacterial genera ratios and comparisons of microbiota composition at all time points, including assessment of effects of helminth infections. ;The prevalence of diarrhea, malaria, anemia, iron deficiency, iron deficiency anemia, inflammation, respiratory tract infections, and other illnesses.