NCT06876389

Effect of Multi Strain Probiotic on Ferritin Levels in Children with Iron Deficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Hasanuddin University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the effect of multi-strain probiotic (bacteria and yeast) on ferritin levels in children age 1 - 18 years old who had iron deficiency in 15 orphanages of Makassar city. The main questions it aims to answer are: • Are ferritin levels in iron deficiency children given iron standard therapy with multi-strain probiotics (bacteria and yeast) higher than those given iron standard therapy with placebo? Researchers will compare iron standard therapy with multi-strain probiotics (bacteria and yeast) to a placebo to see if muti-strain probiotics works to treat iron deficiency in children. Participant will : * Take iron standard therapy with multi-strain probiotics (bacteria and yeast) or iron standard therapy with placebo every day for 30 days * Ferritin levels were evaluated on day 31

Detailed description

The aim of this study was to assess the effect of multi-strain probiotic (bacteria and yeast) on ferritin levels in children with iron deficiency treatment. It is a randomized controlled trial (RCT) conducted in 15 orphanages of Makassar city in children aged 1 - 18 years. The study population was children aged 1 - 18 years who had iron deficiency. Eligible children are randomized into two groups - an intervention group receiving standard iron therapy with multi-strain probiotics (bacteria and yeast) and a control group receiving standard therapy with placebo. The primary outcome is serum ferritin levels, measured at baseline and after 30 days of intervention. Blood samples are collected to measure ferritin levels. The study aims to enroll 80 infants (40 per group) to detect a clinically meaningful difference in ferritin levels between groups. This trial will provide evidence on whether multi strain probiotic can increasing ferritin levels in children with iron deficiency treatment. The results may inform clinical practice regarding the use of probiotics multi strain as an adjunctive therapy for iron deficiency in children.

Conditions

• Iron Deficiency (ID)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	In group A, children with iron deficiency received standard therapy. This group was given standard therapy in the form of elemental Fe 3 mg/kgBB/day/orally and L Bio as 2 packs per day and Saccharomyces boulardii given 2 capsules per day (dose 2 x 250 mg or 2 x (2.5 x109 cells/cfu)) for ages 1 year - 18 years for 30 days.
OTHER	Placebo	In group B, children with iron deficiency received standard therapy with placebo. This group was given standard therapy in the form of elemental Fe 3 mg/kgBB/day/orally and placebo for 30 days.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-09-14
• Completion: 2024-09-30
• First posted: 2025-03-14
• Last updated: 2025-03-18

Locations

1 site across 1 country: Indonesia