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Prebiotic GOS and lactoferrin for beneficial gut microbiota with iron supplements (PREFER)

Prebiotic galacto-oligosaccharides and lactoferrin for beneficial gut microbiota with iron supplements: an intervention trial in infants in Msambweni, Kwale County, southern coastal Kenya

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202009698591500
Enrollment
288
Registered
2020-09-03
Start date
2019-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine

Interventions

Group C
Group B
Group A
Group D

Sponsors

National Institute of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Kenya

Contacts

Public ContactNicole Stoffel

Post Doc at ETH Zurich

nicole.stoffel@hest.ethz.ch+41446328393

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026