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Probiotic Use in Oral Iron Re...

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

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-07-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Iron Deficiency Anemia Treatment Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly assigned via simple randomization method (computer- generated random number sequence)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IRT-Only

Iron deficiency anemia patients receive iron replacement therapy alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

IRT-Pro

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

Group Type EXPERIMENTAL

Lactobacillus plantarum 299v probiotic support

Intervention Type DIETARY_SUPPLEMENT

Addition of Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation to iron replacement therapy.

Interventions

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Lactobacillus plantarum 299v probiotic support

Addition of Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation to iron replacement therapy.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR