Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521879
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Probiotic Use in Oral Iron Replacement Deficiency Anemia Patients Initiating Oral Iron Replacement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improved Gastrointestinal Tolerance and Iron Status Via Probiotic Use in Iron Deficiency Anemia Patients Initiating Oral Iron Replacement
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 ie 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 gdL and serum iron status markers including ferritin ngmL iron µgdL total iron binding capacity TIBC µgdL 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 GPower 319 program based on a power of 80 at a type I error of 005 and an effect size w0261 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 220 IBM Corp Armonk NY Pearson chi-square test Fishers 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 005 was considered statistically significant
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 gdL and serum iron status markers including ferritin ngmL iron µgdL total iron binding capacity TIBC µgdL 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 GPower 319 program based on a power of 80 at a type I error of 005 and an effect size w0261 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 220 IBM Corp Armonk NY Pearson chi-square test Fishers 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 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None