Improved gastrointestinal tolerance and iron status via probiotic use in iron deficiency anaemia patients initiating oral iron replacement: a randomised controlled trial.

2024-11-04
The British journal of nutrition 132(10)
- Gokhan Koker
- Yasin Sahinturk
- Gulhan Ozcelik Koker
- Muhammed Ali Coskuner
- Merve Eren Durmus
- Mehmet Mutlu Catli
- Ayhan Hilmi Cekin

PubMed: 39494607
DOI: 10.1017/s0007114524002757

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 295
Population: 295 patents with newly diagnosed IDA
Methods: prospective randomised non-placebo-controlled study, IRT alone versus IRT plus L. plantarum 299v
Blinding: Open-label
Duration: 3-month IRT
Funding: Unclear

Large Human Trial

This study aimed to investigate gastrointestinal tolerability, treatment persistence and iron status markers in patients with iron deficiency anaemia (IDA) who received oral iron replacement therapy (IRT) with v. without concomitant Lactobacillus plantarum 299v (L. plantarum 299v) probiotic supplementation. A total of 295 patents with newly diagnosed IDA were randomly assigned to receive either IRT alone (n 157, IRT-only group) or IRT plus L. plantarum 299v (n 138, IRT-Pro group) in this prospective randomised non-placebo-controlled study (ClinicalTrials.gov Identifier: NCT06521879). Gastrointestinal intolerance symptoms (at baseline, within the first 30 d of IRT and at any time during 3-month IRT), serum Hb levels (at baseline and 3rd month of IRT) and iron status markers (at baseline and 3rd month of IRT) were recorded. IRT-Pro group, when compared with IRT-only group, experienced significantly lower rates of gastrointestinal intolerance over the course of IRT (13·0 % v. 46·5 %, P < 0·001) and treatment discontinuation within the first 30 d (3·6 % v. 15·9 %, P < 0·001). At 3rd month of therapy, IRT-Pro v. IRT-only group had significantly higher serum levels for iron (76·0 (51·0-96·0) v. 60·0(43·0-70·0) µg/dl, P < 0·001) and transferrin saturation (20·1 (12·5-28·5) v. 14·5 (10·5-19·0) %, P < 0·001) and higher change from baseline Hb (0·9 (0·3-1·3) v. 0·4 (-0·1-1·1) g/dl, P < 0·001) levels. Use of L. plantarum 299v probiotic supplementation during the first 30 d of IRT in IDA patients significantly reduces the gastrointestinal burden of IRT (particularly abdominal pain and bloating), the likelihood of intolerance development (by ∼3 times) and treatment discontinuation (by∼5 times), as accompanied by improved serum Hb levels and serum iron markers.

Research Insights

Lactobacillus plantarum 299v→Improved Iron Levels
IRT-Pro v. IRT-only group had significantly higher serum levels for iron (76·0 (51·0-96·0) v. 60·0(43·0-70·0) µg/dl, P < 0·001)
Effect
Beneficial
Effect size
Moderate
Dose
not specified
Lactobacillus plantarum 299v→Increased Hemoglobin Levels
and higher change from baseline Hb (0·9 (0·3-1·3) v. 0·4 (-0·1-1·1) g/dl, P < 0·001)
Effect
Beneficial
Effect size
Small
Dose
not specified
Lactobacillus plantarum 299v→Increased Transferrin Saturation
and transferrin saturation (20·1 (12·5-28·5) v. 14·5 (10·5-19·0) %, P < 0·001)
Effect
Beneficial
Effect size
Moderate
Dose
not specified
Lactobacillus plantarum 299v→Reduced Gastrointestinal Intolerance
IRT-Pro group, when compared with IRT-only group, experienced significantly lower rates of gastrointestinal intolerance over the course of IRT (13·0 % v. 46·5 %, P < 0·001)
Effect
Beneficial
Effect size
Large
Dose
not specified
Lactobacillus plantarum 299v→Reduced Treatment Discontinuation
and treatment discontinuation within the first 30 d (3·6 % v. 15·9 %, P < 0·001).
Effect
Beneficial
Effect size
Large
Dose
not specified

Adverse Events Reported

Lactobacillus plantarum 299v→gastrointestinal intolerance
IRT-Pro group, when compared with IRT-only group, experienced significantly lower rates of gastrointestinal intolerance over the course of IRT (13·0 % v. 46·5 %, P < 0·001)
Finding
Reported
Lactobacillus plantarum 299v→treatment discontinuation
treatment discontinuation within the first 30 d (3·6 % v. 15·9 %, P < 0·001)
Finding
Reported