N/A
N=288
Prebiotic GOS and Lactoferrin With Iron Supplements
Iron-deficiency
Bottom Line
View on ClinicalTrials.gov: NCT03866837 ↗Enrolled (actual)
288
Serious AEs
1.0%
Results posted
Jan 2025
Primary outcome: Primary: Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 1 Month — 2.208; 1.530; 2.075; 1.292 (unitless)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Galacto-oligosaccharides (Dietary_supplement); Bovine lactoferrin (Dietary_supplement); Multiple micronutrient powders with 5 mg iron (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 1 Month |
2.208; 1.530; 2.075; 1.292 | — |
| SECONDARY Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 6 Months |
1.575; 1.699; 1.779; 1.646 | — |
| SECONDARY Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 9 Months |
2.084; 1.881; 1.916; 1.748 | — |
| SECONDARY Microbiota Composition as Determined by Quantitative Polymerase Chain Reaction (qPCR). |
-0.022; -1.025; -0.002; -0.637; -0.742; -0.786 | — |
| SECONDARY Number of Participants Who Experienced Diarrhea |
7; 6; 7; 4 | — |
| SECONDARY Number of Participants Who Experienced Malaria |
7; 4; 3; 3 | — |
| SECONDARY Proportion of Participants Who Experienced Anemia |
0.43; 0.54; 0.61; 0.49; 0.43; 0.49 | — |
| SECONDARY Proportion of Participants Who Experienced Iron Deficiency |
0.66; 0.61; 0.61; 0.58; 0.3; 0.3 | — |
| SECONDARY Proportion of Participants Who Experienced Iron Deficiency Anemia (IDA) |
0.34; 0.39; 0.45; 0.39; 0.59; 0.58 | — |
| SECONDARY Proportion of Participants Who Experienced Inflammation |
0.09; 0.15; 0.15; 0.14; 0.12; 0.11 | — |
| SECONDARY Number of Participants Who Experienced Respiratory Tract Infections |
40; 36; 41; 38 | — |
| SECONDARY Other Illnesses |
16; 10; 17; 28; 3; 5 | — |
Summary
The ultimate goal of this research is to develop a means to safely administer iron supplements to infants in settings with a high infection burden. The investigators will conduct a randomized clinical trial in 6 month-old Kenyan infants in conjunction with mechanistic microbiota studies using a novel long-term continuous polyfermenter platform inoculated with immobilized fecal microbiota from Kenyan infants. Oral iron supplements are associated with a significant 15% increase in the rate of diarrhea in children in malaria-endemic areas. The most recent studies have shown that prebiotic galacto-oligosaccharides (GOS) can provide partial amelioration of the adverse effects of iron supplementation by enhancing the growth of barrier populations of bifidobacteria and lactobacilli. The investigators hypothesize that the combination of GOS with bovine lactoferrin, adding iron sequestration as well as antimicrobial and immunomodulatory activities, will provide almost complete protection against the adverse effects of added iron on the intestinal microbiota.
Eligibility Criteria
Inclusion Criteria
- vaginal or cesarean delivery
- an infant age of 6 months (±3 weeks)
- mother ≥15 years of age
- infant still breastfeeding
- anticipated residence in the area for the study duration.
Exclusion Criteria
- inability to provide informed consent
- hemoglobin < 70 g/L
- Z scores for weight-for-age (WAZ) or weight-for-height (WHZ) <3,
- any maternal or infant chronic illness
- administration of any infant vitamin or mineral supplements for the past 2 months
- history of infant antibiotic treatment within 7 days before study enrollment.
Data sourced from ClinicalTrials.gov (NCT03866837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.