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The Effect of the Prebiotic Galacto-oligosaccharide on Iron Absorption With Micronutrient Powders in Kenyan Infants

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ClinicalTrials.gov Identifier: NCT03357510
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Brief Summary:
The purpose of this study is to determine whether single doses of the prebiotic galacto-oligosaccharide (GOS) added to iron-fortified meals with micronutrient powders increase iron absorption compared to a 3 weeks pre-feeding of GOS.

Condition or disease Intervention/treatment Phase
Iron-deficiency Dietary Supplement: FeSO4 with GOS Dietary Supplement: FeSO4 with no GOS Dietary Supplement: FeFum+NaFeEDTA with GOS Dietary Supplement: FeFum+NaFeEDTA with no GOS Not Applicable

Detailed Description:

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA by ensuring that the iron needs of infants and young children are met with-out changing their traditional diet. However, MNPs containing a high dose of 12.5 mg of iron adversely affect the African infant gut microbiome by decreasing beneficial 'barrier' commensals, like Bifidobacteria, while increasing enterobacteria, specific enteropathogens, e.g. pathogenic Escherichia coli. Furthermore, the risk for gut inflammation, diarrhoea and respiratory tract infections (RTIs) might increase. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. In a recent trial in Kenya, the investigators demonstrated that iron dose in MNP can be reduced to 5 mg and still be efficacious in reducing anemia and all measures of iron deficiency. Also, addition of prebiotic to it reduces adverse effects on the gut of the infant, resulting in greater abundances of Bifidobacteria and Lactobacilli, lower abundances of virulence and toxin genes of pathogens and less enterocyte damage and a lower incidence of treated RTIs. Further, the investigators also showed that prior consumption of the galacto-oligosaccharide (GOS) for 3 weeks increases iron absorption from the MNP containing sodium iron ethylenediaminetetraacetate (NaFeEDTA) and ferrous fumarate (FeFum), possibly reflecting greater colonic iron absorption.

To complement the results of the enhancing effect on iron absorption of GOS and to confirm the suggested mechanism of being colonic iron absorption, the investigators would like to test whether GOS increases iron absorption if it is given without 3 weeks of pre-feeding via a potential change of the meal matrix rather than changes in the gut microbiome as seen with the 3 weeks of prior consumption of GOS.

The above mentioned studies showing an increase in RTIs with consumption of the high iron dose MNP and recently conducted study that showed a decrease in RTIs if the prebiotic GOS is added to the MNP need further investigation to understand the underlying mechanism on how iron and prebiotic influence the occurrence of RTIs. To take a first step, the investigators would therefore like to investigate the nasopharyngeal microbiome of infants consuming iron syrup, as changes in pathogen colonization of the respiratory epithelium is one possible mechanism on how iron and prebiotics might influence the incidence of RTIs.

The investigators will compare the fractional iron absorption (FIA) of the iron with and without co-consumption of the GOS prebiotic in Kenyan infants consuming a maize porridge. This study will follow on recently concluded studies in the Kwale County. 22 infants will be enrolled. On 2 consecutive study days, these infants will consume a test meal with 2 iron compounds (NaFeEDTA and FeFum) and a reference test meal with ferrous sulfate (FeSO4) all with GOS. Fourteen days later, they will consume all the test meals without GOS on 2 consecutive study days. The investigators will then assess the relative effects of co-consumption of GOS on absorption of the three compounds. The hypothesis is that co-consumption of GOS with the iron in the test meals will not increase absorption of iron from the three compounds, compared to no co-consumption of GOS.

In the same infants collect a fecal sample and a nasopharyngeal sample will be collected to determine the microbiome changes before and after consumption of iron containing syrups.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of the Prebiotic Galacto-oligosaccharide on Iron Absorption From a New Micronutrient Powder for Fortification of Infant Foods in Sub-Saharan Africa
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Placebo Comparator: FeSO4 with GOS
labeled iron sulfate FeSO4 (5 mg/test meal): one test meal with prebiotic galacto-oligosaccharide GOS and one with no prebiotic galacto-oligosaccharide GOS
Dietary Supplement: FeSO4 with GOS
7.5 g of the prebiotic galacto-oligosaccharides (GOS) and 5 mg ferrous sulfate (FeSO4) to test meals; Prebiotic fibers, are know to positively affect the gut microbiota composition by increasing populations of healthy bacteria such as bifidocbacteria and lactobacilli and creating a strong barrier against pathogens in the human intestine; GOS are a mixture of various galactose-based di- and oligosaccharides of 2-8 saccharide units of different structure that are enzymatically produced from lactose.

Placebo Comparator: FeFum+NaFeEDTA with GOS
test meal includes 2 iron compounds: 2.5 mg labeled ferrous fumarate FeFum and 2.5 mg labeled sodium iron ethylenediaminetetraacetate NaFeEDTA with prebiotic galacto-oligosaccharide (GOS)
Dietary Supplement: FeFum+NaFeEDTA with GOS
7.5 g of the prebiotic galacto-oligosaccharides (GOS) to test meals and 5 mg of iron mix (2.5 mg ferrous fumarate (FeFum) + 2.5 mg NaFeEDTA); Prebiotic fibers, are know to positively affect the gut microbiota composition by increasing populations of healthy bacteria such as bifidocbacteria and lactobacilli and creating a strong barrier against pathogens in the human intestine; GOS are a mixture of various galactose-based di- and oligosaccharides of 2-8 saccharide units of different structure that are enzymatically produced from lactose.

Placebo Comparator: FeSO4 with no GOS
labeled iron sulfate FeSO4 (5 mg/test meal): one test meal with no prebiotic galacto-oligosaccharide GOS
Dietary Supplement: FeSO4 with no GOS
no prebiotic galacto-oligosaccharide (GOS) to test meals but 5 mg ferrous sulfate (FeSO4)

Placebo Comparator: FeFum+NaFeEDTA with no GOS
test meal includes 2 iron compounds: 2.5 mg labeled ferrous fumarate FeFum and 2.5 mg labeled sodium iron ethylenediaminetetraacetate NaFeEDTA with no prebiotic galacto-oligosaccharide (GOS)
Dietary Supplement: FeFum+NaFeEDTA with no GOS
7.5 g of the prebiotic galacto-oligosaccharides (GOS) to test meals but 5 mg of iron mix (2.5 mg ferrous fumarate (FeFum) + 2.5 mg NaFeEDTA)




Primary Outcome Measures :
  1. Fractional iron absorption [ Time Frame: Measured at 14 days after last test meals (Day 34) from blood draw ]
    Fractional iron absorption from MNPs containing 3 different iron compounds (FeSO4, NaFeEDTA and FeFum), consumed with and without the prebiotic GOS


Secondary Outcome Measures :
  1. Nasopharyngeal microbiome [ Time Frame: After Iron absorption study at Day 35 (serves as baseline) and 1 month later at Day 63 (serves as endpoint) ]
    Infant's nasopharyngeal microbiome before and after one month of iron syrup treatment

  2. Gut microbiome [ Time Frame: After Iron absorption study at Day 35 (serves as baseline) and 1 month later at Day 63 (serves as endpoint) ]
    Infant's gut microbiome before and after one month of iron syrup treatment



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Ages Eligible for Study:   6 Months to 14 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of 6-14 months at baseline
  • Assessment of good health as assessed by professional staff at Msambweni District Hospital
  • The caregiver is willing to participate in the study
  • The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)

Exclusion Criteria:

  • Hemoglobin <70 g/L
  • Severe underweight (Z-score weight-for-age <−3)
  • Severe wasting (Z-score weight-for-height<−3)
  • Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a par-ticipant in the trial or would render the participant unable to comply with the protocol
  • Participants taking part in other studies requiring the drawing of blood
  • Not planning long-term residence in study site
  • Regular intake (>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357510


Contacts
Contact: Nadja Mikulic +41 44 632 42 73 nadja.mikulic@hest.ethz.ch
Contact: Michael Zimmermann, Dr. +41 44 632 86 57 michael.zimmermann@hest.ethz.ch

Locations
Kenya
Msambweni District Hopsital
Msambweni, Kwale County, Kenya
Sponsors and Collaborators
Swiss Federal Institute of Technology

Responsible Party: Prof. Michael B. Zimmermann, Head of Laboratory of Human Nutrition, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03357510     History of Changes
Other Study ID Numbers: Fe_AcuteGOS
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Ferrous fumarate
Micronutrients
Fesoterodine
Fe(III)-EDTA
Edetic Acid
Ferric Compounds
Growth Substances
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Anticoagulants
Calcium Chelating Agents
Hematinics