Clinical trial NCT06876389: Effect of Multi Strain Probiotic on Ferritin Levels in Children with Iron Deficiency
Official title: Effect of Multi Strain Probiotic on Ferritin Levels in Children with Iron Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency (ID)
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ferritin level
timeFrame: Ferritin level was measured after 30th days of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Hasanuddin University
state: South Sulawesi
Study officials:
References: