Completed

Probiotics for Better Gastrointestinal Tolerance in Iron Deficiency Anemia

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Study Aim

This study aims to evaluate if taking Lactobacillus plantarum 299v probiotic with oral iron can improve gastrointestinal comfort and treatment adherence in people with iron deficiency anemia.

What is being tested

Lactobacillus plantarum 299v probiotic support

Dietary Supplement
Who is being recruted

Iron Deficiencies+6

+ Anemia

+ Anemia, Hypochromic

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2022
See protocol details

Summary

Principal SponsorAntalya Training and Research Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2022

Actual date on which the first participant was enrolled.

This study is focused on improving the treatment experience for adults with newly diagnosed iron deficiency anemia (IDA). It aims to assess whether adding a probiotic, L. plantarum 299v, to the standard iron replacement therapy (IRT) can reduce uncomfortable digestive issues that often accompany iron supplements. The study includes patients who have not previously received iron treatment and excludes those with conditions like celiac disease or irritable bowel syndrome. This research is important as it seeks to make iron treatment more tolerable, potentially improving adherence and outcomes for patients with IDA. Participants in the study are randomly divided into two groups: one receives just the iron supplement (ferrous sulfate) at 100 mg daily, while the other also takes a daily probiotic for the first month. Researchers measure symptoms like nausea and constipation at the start, after 30 days, and throughout the three-month treatment to see if the probiotic helps. They also monitor iron levels in the blood to evaluate the effectiveness of the treatment. The study considers how many patients stop treatment due to discomfort, aiming to find if the probiotic can help reduce this issue.

Official TitleImproved Gastrointestinal Tolerance and Iron Status Via Probiotic Use in Iron Deficiency Anemia Patients Initiating Oral Iron Replacement
NCT06521879
Principal SponsorAntalya Training and Research Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

295 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesAnemiaAnemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, Iron-DeficiencyIron Metabolism Disorders

Criteria

1 inclusion criteria required to participate
Treatment-naïve patients diagnosed with newly diagnosed iron deficiency anemia

5 exclusion criteria prevent from participating
Irritable bowel syndrome

Celiac disease

Untreated active menometrorrhagia

Hemorrhoidal disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Iron deficiency anemia patients receive iron replacement therapy plus L. plantarum 299v probiotic support

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)Open Antalya Training and Research Hospital in Google Maps
CompletedOne Study Center
Probiotics for Better Gastrointestinal Tolerance in Iron Deficiency Anemia | PatLynk