CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 195 enrolled
Drug / intervention
FeFum and 7.5 g prebiotic mixture +2 moredietary
Likely dose
FeFum and 7.5 g prebiotic mixturefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03894358
NCT03894358N/ACompleted
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Iron Absorption From a Wheat-based Instant Cereal Containing Ferrous Fumarate and Ascorbic Acid With and Without Prebiotics: Gut Microbiome and Stable Isotope Studies in Kenyan Infants

Swiss Federal Institute of Technology·interventional·Posted Mar 28, 2019·Updated May 12, 2020

In Brief

A clinical study evaluating FeFum and 7.5 g prebiotic mixture, FeFum and 3 g prebiotic mixture, and 1 other intervention for Iron Absorption and Gut Microbiota. Completed, enrolled 195 participants across 1 site.

Detailed Summary

The aim of this study is to measure the effect of a prebiotic (high dose/low dose) mixture at different doses within a wheat-based instant cereal, on fractional iron absorption (FIA), gut microbiota and inflammation after three weeks. FIA will be compared with and without three weeks of pre-feeding with two different doses of the prebiotic mixture.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Absorption, Gut Microbiota
CountriesKenya
CollaboratorsDanone Nutricia Research

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 28, 2019
Enrollment StartJul 23, 2019
Primary CompletionJan 4, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.3 years ago

Interventions

FeFum and 7.5 g prebiotic mixturedietary

The 3 weeks intervention will consist of 24 g of wheat-based instant cereal and 90 ml of water per portion and will contain 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) plus 7.5 g prebiotics mixture The absorption study test meals will consist of 24 g wheat-based instant cereal and 90 ml of water per portion and additionally: Test meal 1 will be composed of: 3.6 mg of Fe as 57FeFum and 0 g prebiotic mixture added extrinsically. Test meal 2 will be composed of: 3.6 mg of Fe as 1.5 mg iron as 58FeFum, 2.09 mg iron as 56FeFum and 7.5 g prebiotic mixture added extrinsically.

FeFum and 3 g prebiotic mixturedietary

Standard wheat-based instant cereal containing 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) plus 3 g prebiotics mixture per portion

Fefum and no prebiotic mixturedietary

Standard wheat-based instant cereal containing 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) per portion.