Iron Deficiency Anemia TreatmentNCT06521879
Probiotic Use in Oral Iron Replacement Deficiency Anemia Patients Initiating Oral Iron Replacement
A study testing Lactobacillus plantarum 299v probiotic support in people with Iron Deficiency Anemia Treatment and Iron Deficiency Anemia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia Treatment, Iron Deficiency Anemia
- What is being tested?
- Lactobacillus plantarum 299v probiotic support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment-naïve patients diagnosed with newly diagnosed iron deficiency anemia
Who cannot join
- Irritable bowel syndrome
- Celiac disease
- Untreated active menometrorrhagia
- Hemorrhoidal disease
- Previous iron replacement therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, 07050
About this study
Official title: 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
Read the 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.
- Being tested
- Lactobacillus plantarum 299v probiotic support
- Keywords
- iron deficiency anemia, oral iron replacement, probiotic supplementation, Lactobacillus plantarum 299v, gastrointestinal tolerability, iron status markers
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum 299v probiotic supportDietary supplement
Addition of Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation to iron replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| IRT-Only | No intervention | Iron deficiency anemia patients receive iron replacement therapy alone. |
| IRT-Pro | Experimental | Iron deficiency anemia patients receive iron replacement therapy plus L. plantarum 299v probiotic support Receives: Dietary Supplement: Lactobacillus plantarum 299v probiotic support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerance and Treatment Compliance in Iron Deficiency Anemia Patients Using Oral Iron with or without Lactobacillus plantarum 299v Probiotic Supplementation
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned via simple randomization method (computer- generated random number sequence)
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gokhan Koker, MD, Principal investigator, Antalya Training and Research HospitalYasin Sahinturk, MD, Study chair, Antalya Training and Research HospitalGulhan Ozcelik Koker, MD, Study chair, Antalya Training and Research HospitalAli Coskuner, MD, Study chair, Antalya Training and Research HospitalMerve Eren Durmuş, MD, Study chair, Antalya Training and Research HospitalMutlu M Catli, MD, Study chair, Antalya Training and Research HospitalAyhan H Cekin, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521879
- Sponsor's protocol ID
- 2020-265
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013 Jul;1(1):e16-25. doi: 10.1016/S2214-109X(13)70001-9. Epub 2013 Jun 25.
PubMed 25103581Kumar SB, Arnipalli SR, Mehta P, Carrau S, Ziouzenkova O. Iron Deficiency Anemia: Efficacy and Limitations of Nutritional and Comprehensive Mitigation Strategies. Nutrients. 2022 Jul 20;14(14):2976. doi: 10.3390/nu14142976.
PubMed 35889932Seo H, Yoon SY, Ul-Haq A, Jo S, Kim S, Rahim MA, Park HA, Ghorbanian F, Kim MJ, Lee MY, Kim KH, Lee N, Won JH, Song HY. The Effects of Iron Deficiency on the Gut Microbiota in Women of Childbearing Age. Nutrients. 2023 Jan 30;15(3):691. doi: 10.3390/nu15030691.
PubMed 36771397Zakrzewska Z, Zawartka A, Schab M, Martyniak A, Skoczen S, Tomasik PJ, Wedrychowicz A. Prebiotics, Probiotics, and Postbiotics in the Prevention and Treatment of Anemia. Microorganisms. 2022 Jun 30;10(7):1330. doi: 10.3390/microorganisms10071330.
PubMed 35889049Goodnough LT, Nemeth E, Ganz T. Detection, evaluation, and management of iron-restricted erythropoiesis. Blood. 2010 Dec 2;116(23):4754-61. doi: 10.1182/blood-2010-05-286260. Epub 2010 Sep 8.
PubMed 20826717Vonderheid SC, Tussing-Humphreys L, Park C, Pauls H, OjiNjideka Hemphill N, LaBomascus B, McLeod A, Koenig MD. A Systematic Review and Meta-Analysis on the Effects of Probiotic Species on Iron Absorption and Iron Status. Nutrients. 2019 Dec 3;11(12):2938. doi: 10.3390/nu11122938.
PubMed 31816981Korcok DJ, Trsic-Milanovic NA, Ivanovic ND, Dordevic BI. Development of Probiotic Formulation for the Treatment of Iron Deficiency Anemia. Chem Pharm Bull (Tokyo). 2018 Apr 1;66(4):347-352. doi: 10.1248/cpb.c17-00634. Epub 2018 Jan 19.
PubMed 29353864Rusu IG, Suharoschi R, Vodnar DC, Pop CR, Socaci SA, Vulturar R, Istrati M, Morosan I, Farcas AC, Kerezsi AD, Muresan CI, Pop OL. Iron Supplementation Influence on the Gut Microbiota and Probiotic Intake Effect in Iron Deficiency-A Literature-Based Review. Nutrients. 2020 Jul 4;12(7):1993. doi: 10.3390/nu12071993.
PubMed 32635533Bazeley JW, Wish JB. Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. Am J Kidney Dis. 2022 Jun;79(6):868-876. doi: 10.1053/j.ajkd.2021.09.017. Epub 2021 Nov 7.
PubMed 34758368Kumar A, Sharma E, Marley A, Samaan MA, Brookes MJ. Iron deficiency anaemia: pathophysiology, assessment, practical management. BMJ Open Gastroenterol. 2022 Jan;9(1):e000759. doi: 10.1136/bmjgast-2021-000759.
PubMed 34996762Gomez-Ramirez S, Brilli E, Tarantino G, Munoz M. Sucrosomial(R) Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097.
PubMed 30287781Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.
PubMed 26408108Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
PubMed 25700159Deschemin JC, Noordine ML, Remot A, Willemetz A, Afif C, Canonne-Hergaux F, Langella P, Karim Z, Vaulont S, Thomas M, Nicolas G. The microbiota shifts the iron sensing of intestinal cells. FASEB J. 2016 Jan;30(1):252-61. doi: 10.1096/fj.15-276840. Epub 2015 Sep 14.
PubMed 26370847Jaeggi T, Kortman GA, Moretti D, Chassard C, Holding P, Dostal A, Boekhorst J, Timmerman HM, Swinkels DW, Tjalsma H, Njenga J, Mwangi A, Kvalsvig J, Lacroix C, Zimmermann MB. Iron fortification adversely affects the gut microbiome, increases pathogen abundance and induces intestinal inflammation in Kenyan infants. Gut. 2015 May;64(5):731-42. doi: 10.1136/gutjnl-2014-307720. Epub 2014 Aug 20.
PubMed 25143342
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Gastrointestinal Tolerance and Iron Status Via Probiotic Use in Iron Deficiency Anemia Patients Initiating Oral Iron Replacement
- ClinicalTrials.gov ID
- NCT06521879
- Acronym / sponsor ID
- 2020-265
- Keywords
- iron deficiency anemia, oral iron replacement, probiotic supplementation, Lactobacillus plantarum 299v, gastrointestinal tolerability, iron status markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly assigned via simple randomization method (computer- generated random number sequence)
| Arm | Type | Receives |
|---|---|---|
| IRT-Only | No intervention | –Iron deficiency anemia patients receive iron replacement therapy alone. |
| IRT-Pro | Experimental | Dietary Supplement: Lactobacillus plantarum 299v probiotic supportIron deficiency anemia patients receive iron replacement therapy plus L. plantarum 299v probiotic support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Treatment-naïve patients diagnosed with newly diagnosed iron deficiency anemia
Key exclusion criteria (5 listed)
- Irritable bowel syndrome
- Celiac disease
- Untreated active menometrorrhagia
- Hemorrhoidal disease
- Previous iron replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarum 299v probiotic supportAddition of Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation to iron replacement therapy. | Dietary supplement | IRT-Pro |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 25103581Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013 Jul;1(1):e16-25. doi: 10.1016/S2214-109X(13)70001-9. Epub 2013 Jun 25.
- Background: PubMed 35889932Kumar SB, Arnipalli SR, Mehta P, Carrau S, Ziouzenkova O. Iron Deficiency Anemia: Efficacy and Limitations of Nutritional and Comprehensive Mitigation Strategies. Nutrients. 2022 Jul 20;14(14):2976. doi: 10.3390/nu14142976.
- Background: PubMed 36771397Seo H, Yoon SY, Ul-Haq A, Jo S, Kim S, Rahim MA, Park HA, Ghorbanian F, Kim MJ, Lee MY, Kim KH, Lee N, Won JH, Song HY. The Effects of Iron Deficiency on the Gut Microbiota in Women of Childbearing Age. Nutrients. 2023 Jan 30;15(3):691. doi: 10.3390/nu15030691.
- Background: PubMed 35889049Zakrzewska Z, Zawartka A, Schab M, Martyniak A, Skoczen S, Tomasik PJ, Wedrychowicz A. Prebiotics, Probiotics, and Postbiotics in the Prevention and Treatment of Anemia. Microorganisms. 2022 Jun 30;10(7):1330. doi: 10.3390/microorganisms10071330.
- Background: PubMed 20826717Goodnough LT, Nemeth E, Ganz T. Detection, evaluation, and management of iron-restricted erythropoiesis. Blood. 2010 Dec 2;116(23):4754-61. doi: 10.1182/blood-2010-05-286260. Epub 2010 Sep 8.
- Background: PubMed 31816981Vonderheid SC, Tussing-Humphreys L, Park C, Pauls H, OjiNjideka Hemphill N, LaBomascus B, McLeod A, Koenig MD. A Systematic Review and Meta-Analysis on the Effects of Probiotic Species on Iron Absorption and Iron Status. Nutrients. 2019 Dec 3;11(12):2938. doi: 10.3390/nu11122938.
- Background: PubMed 29353864Korcok DJ, Trsic-Milanovic NA, Ivanovic ND, Dordevic BI. Development of Probiotic Formulation for the Treatment of Iron Deficiency Anemia. Chem Pharm Bull (Tokyo). 2018 Apr 1;66(4):347-352. doi: 10.1248/cpb.c17-00634. Epub 2018 Jan 19.
- Background: PubMed 32635533Rusu IG, Suharoschi R, Vodnar DC, Pop CR, Socaci SA, Vulturar R, Istrati M, Morosan I, Farcas AC, Kerezsi AD, Muresan CI, Pop OL. Iron Supplementation Influence on the Gut Microbiota and Probiotic Intake Effect in Iron Deficiency-A Literature-Based Review. Nutrients. 2020 Jul 4;12(7):1993. doi: 10.3390/nu12071993.
- Background: PubMed 34758368Bazeley JW, Wish JB. Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. Am J Kidney Dis. 2022 Jun;79(6):868-876. doi: 10.1053/j.ajkd.2021.09.017. Epub 2021 Nov 7.
- Background: PubMed 34996762Kumar A, Sharma E, Marley A, Samaan MA, Brookes MJ. Iron deficiency anaemia: pathophysiology, assessment, practical management. BMJ Open Gastroenterol. 2022 Jan;9(1):e000759. doi: 10.1136/bmjgast-2021-000759.
- Background: PubMed 30287781Gomez-Ramirez S, Brilli E, Tarantino G, Munoz M. Sucrosomial(R) Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097.
- Background: PubMed 26408108Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokhan Koker, MD principal investigator
Antalya Training and Research Hospital
Yasin Sahinturk, MD study chair
Antalya Training and Research Hospital
Gulhan Ozcelik Koker, MD study chair
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum 299v probiotic support in people with Iron Deficiency Anemia Treatment and Iron Deficiency Anemia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521879, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.