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

NCT06876389 | Completed DMC

• 1 other identifier: UH24040220
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Iron Deficiency (ID)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Children with Iron deficiency who receive iron standard therapy and probiotic multi strain 2 capsules per day for 30 days

Dietary Supplement: Probiotic

Group B

PLACEBO COMPARATOR

Children with Iron deficiency who receive iron standard therapy and placebo

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Group A

Placebo OTHER

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.

Group B

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric resident

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: July 1, 2024
• Primary Completion: September 14, 2024
• Study Completion: September 30, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

ID (1)