Probiotic Use in Oral Iron Replacement Deficiency Anemia Patients Initiating Oral Iron Replacement

July 25, 2024 updated by: Antalya Training and Research Hospital

Improved Gastrointestinal Tolerance and Iron Status Via Probiotic Use in Iron Deficiency Anemia Patients Initiating Oral Iron Replacement

Investigation of gastrointestinal tolerability, treatment compliance and iron status markers in patients with iron deficiency anemia who received oral iron replacement therapy with versus without concomitant probiotic supplementation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 295 patients, with newly diagnosed iron deficiency anemia (IDA) who were planned to receive routine oral IRT were included in this prospective randomized non-placebo, controlled 3-month follow-up study. Patients were randomly assigned via simple randomization method to receive either iron replacement therapy (IRT) alone or IRT plus L. plantarum 299v probiotic support . Adult (aged older than18 years) treatment-naïve patients diagnosed with newly diagnosed IDA without previous IRT were included in the study, while those with irritable bowel syndrome, previous IRT therapy or intolerance to IRT and those with a known chronic disease (i.e., inflammatory bowel disease (IBD), celiac disease) or untreated active menometrorrhagia and hemorrhoid were excluded from the study.

All patients received IRT with ferrous sulfate (Fe2 + ) preparation (100 mg, once daily) for 3 months, while those in the IRT-Pro group also received daily (10B CFU) L. plantarum 299v probiotic supplementation for 30 days starting from the first day of IRT.

Data on gastrointestinal intolerance symptoms (loss of appetite, nausea, vomiting, abdominal pain, diarrhea, constipation and bloating) were recorded at three time points including baseline, within the first 30 days of IRT and at any time during 3-month IRT.

Serum hemoglobin levels (g/dL) and serum iron status markers including ferritin (ng/mL), iron (µg/dL), total iron binding capacity (TIBC, µg/dL) and transferrin saturation (%) were recorded at baseline and at 3 rd month of IRT. Data on treatment discontinuation were also recorded in study groups along with comparison of study variables in patients with vs. without treatment discontinuation within the first 30 days of IRT.

At least 189 patients were calculated to be included via sample size estimation (G*Power 3.1.9 program) based on a power of 80 % at a type I error of 0.05, and an effect size (w=0.261) calculated using data from a previous study by Cekin et al. .

Given the high likelihood of missing data, a total of 200 patients were planned to be included in the study population with the use of 25% lost to follow up ratio. Statistical analysis was made using IBM SPSS Statistics for Windows, Version 22.0 (IBM Corp., Armonk, NY). Pearson chi-square test, Fisher's exact test and Mc-Nemar test were used for analysis of categorical variables. Mann-Whitney U test was used for analysis of non-normally distributed numerical data while independent sample t test was used for normally distributed data. The number needed to treat (NNT) analysis was performed to determine how many patients must receive IRT-Pro instead of IRT per se to prevent one additional treatment discontinuation. Data are expressed as mean ± standard deviation (SD), median, inter-quartile range (IQR), minimum-maximum and percent (%) where appropriate. p < 0.05 was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07050
        • Antalya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Treatment-naïve patients diagnosed with newly diagnosed iron deficiency anemia

Exclusion Criteria:

  • Irritable bowel syndrome
  • Celiac disease
  • Untreated active menometrorrhagia
  • Hemorrhoidal disease
  • Previous iron replacement therapy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: IRT-Only
Iron deficiency anemia patients receive iron replacement therapy alone.
Experimental: IRT-Pro
Iron deficiency anemia patients receive iron replacement therapy plus L. plantarum 299v probiotic support
Dietary supplement: Lactobacillus plantarum 299v probiotic support
Addition of Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation to iron replacement therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Tolerance and Treatment Compliance in Iron Deficiency Anemia Patients Using Oral Iron with or without Lactobacillus plantarum 299v Probiotic Supplementation
Time Frame: 3 months

To investigate gastrointestinal tolerability and treatment compliance in patients with iron deficiency anemia who received oral iron replacement therapy with versus without concomitant Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation. Gastrointestinal intolerance symptoms (loss of appetite, nausea, vomiting, abdominal pain, diarrhea, constipation, and bloating) will be assessed using a structured questionnaire with yes or no questions.

Measurement Tool: Structured Questionnaire

Data Collection Points: Baseline, within the first 30 days of iron replacement therapy (IRT), and at any time during the 3-month IRT.

Scale Description: The questionnaire will include yes or no questions to determine the presence of gastrointestinal intolerance symptoms. A "yes" response indicates the presence of a symptom, and a "no" response indicates its absence.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Gokhan Koker, MD, Antalya Training and Research Hospital
  • Study Chair: Yasin Sahinturk, MD, Antalya Training and Research Hospital
  • Study Chair: Gulhan Ozcelik Koker, MD, Antalya Training and Research Hospital
  • Study Chair: Ali Coskuner, MD, Antalya Training and Research Hospital
  • Study Chair: Merve Eren Durmuş, MD, Antalya Training and Research Hospital
  • Study Chair: Mutlu M Catli, MD, Antalya Training and Research Hospital
  • Study Director: Ayhan H Cekin, MD, Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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