# Prebiotic GOS and lactoferrin for beneficial gut microbiota with iron supplements

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2021 · $525,186

## Abstract

Other Project Information: Project Summary/Abstract
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 hypothesis underlying this project is that promoting development of a
beneficial, protective gut microbiota by co-administration of prebiotic galacto-oligosaccharides (GOS) and iron-
sequestering bovine lactoferrin (bLF) during iron supplementation will prevent iron-induced increases of
opportunistic enteropathogens that cause infection and inflammation. The proposed research will extend our
established strategy of conjoining investigations in vivo with intestinal fermentation and cellular models in vitro.
We will conduct a randomized clinical trial in 6 month-old Kenyan infants in conjunction with mechanistic
microbiota studies using our established long-term continuous polyfermenter platform inoculated with
immobilized fecal microbiota from Kenyan infants. The period from about 6 months to 1 year of age is vital both
for iron nutrition and for the establishment of a healthy gut microbiome that promotes immune system
development, local immune homeostasis and limits pathogen colonization. Oral iron supplements are
associated with a significant 15% increase in the rate of diarrhea in children in malaria-endemic areas. Our
most recent studies have shown that prebiotic galacto-oligosaccharides (GOS) can provide partial amelioration
of the adverse effects of iron-induced dysbiosis by enhancing the growth of barrier populations of bifidobacteria
and lactobacilli. We hypothesize that the combination of prebiotic GOS with bovine lactoferrin (bLF), adding
iron sequestration, antimicrobial and immunomodulatory activities, will provide virtually complete protection
against the adverse effects of added iron on the intestinal microbiota. Our research has two specific aims:
 (1) to conduct a randomized, controlled double-blind 9-month clinical trial in 6-month old Kenyan infants
 comparing the effects on gut microbiome composition among groups receiving in-home fortification
 for 6 months with micronutrient powders containing 5 mg iron (as sodium iron EDTA [2.5 mg] and
 ferrous fumarate [2.5 mg]) and (i) galacto-oligosaccharides (GOS; 7.5 g), (ii) bovine lactoferrin (bLF, 1.0
 g), (iii) GOS (7.5 g) and bLF (1.0 g), and (iv) no GOS or bLF. Each infant will then be followed for an
 additional 3 months to determine the longer-term effects of the treatments.
 (2) to examine mechanisms of prebiotic GOS and iron-sequestering bLF on microbiota composition,
 enteropathogen development, microbiota functions and metabolic activity, and inflammatory potential
 in vitro with treatments paralleling those in Specific Aim 1, using immobilized fecal microbiota from
 Kenyan infants to inoculate our established long-term continuous polyfermenter intestinal model
 (PolyFermS) to mimic Kenyan infant colon conditions, together with cellular studies.

## Key facts

- **NIH application ID:** 10163166
- **Project number:** 5R01DK115449-04
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Gary M Brittenham
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $525,186
- **Award type:** 5
- **Project period:** 2018-08-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10163166

## Citation

> US National Institutes of Health, RePORTER application 10163166, Prebiotic GOS and lactoferrin for beneficial gut microbiota with iron supplements (5R01DK115449-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10163166. Licensed CC0.

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