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

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

Study Overview

• Status: Completed
• Conditions: Iron Deficiency (ID)
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia, 90245
      • Hasanuddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children with iron deficiency
• Age 1 year - 18 years
• The parent or person in charge of the foundation signed the informed consent that the child was willing to be included in the study.

Exclusion Criteria:

• Iron deficiency children with infection, renal impairment and hepatic impairment were identified through interviews with caregivers and physical examination of the children.
• Children with immunocompromise (malignancy, malnutrition, HIV).
• Iron deficiency children who have received iron therapy and last consumed 3 months prior to the study.
• Iron deficiency children who were temporarily receiving iron therapy or iron supplementation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Children with Iron deficiency who receive iron standard therapy and probiotic multi strain 2 capsules per day for 30 days	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.
Placebo Comparator: Group B; Children with Iron deficiency who receive iron standard therapy and placebo	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ferritin level	We compare the ferritin levels between children with iron deficiency who received standard iron therapy with probiotic multi-strain and those who received standard iron therapy with placebo	Ferritin level was measured after 30th days of intervention

Collaborators and Investigators

• Sponsor: Hasanuddin University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 14, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Iron Deficiencies; Anemia, Iron-Deficiency
• Other Study ID Numbers: UH24040220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No