Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Apr 23;25(1):98.
doi: 10.1186/s12894-025-01725-7.

Efficacy of lactoferrin in preventing recurrent urinary tract infections in pregnant Egyptian women: a randomized controlled trial

Ahmed Shoukry  1 , Yasser ElKassar  2 , Michaella K Hezagirwa  2 , Rehab El-Said  2
Affiliations
Randomized Controlled Trial

Efficacy of lactoferrin in preventing recurrent urinary tract infections in pregnant Egyptian women: a randomized controlled trial

Ahmed Shoukry et al. BMC Urol. .

Abstract

Background: Prevention of a very prevalent problem such as urinary tract infections (UTIs), is of utmost importance, particularly during pregnancy, in order to limit the irrational use of antibiotics. Lactoferrin (Lf) has proven in vivo and in vitro antibacterial actions, especially against Escherichia coli, which is the main causative organism of UTIs. The study question is, "Does the administration of Lf to pregnant women with a history of RUTIs reduce the incidence of new episodes of UTIs during pregnancy?".

Methods: This was a randomized controlled study over 6 months that started from February 2024 to August 2024, conducted at the antenatal clinic of El-Shatby University Hospital, Alexandria, Egypt. The study included 220 pregnant women (14-24 weeks' gestation) who had experienced two or more UTI episodes in the previous six months. A negative urine culture right before enrollment was an inclusion criterion. Participants were randomly allocated into two groups; 110 women received a daily dose of 200 mg of lactoferrin, and 110 women as controls. Women were followed up by urine cultures and sensitivity monthly, and they were asked to report any symptoms of UTIs present. The outcomes were the number of episodes of asymptomatic bacteriuria (ASB), acute cystitis, or pyelonephritis in both groups.

Results: A total of 874 urine samples were collected from women in both groups (438 from the Lf group and 436 from the control group), and their results were analyzed. Over the follow-up period we diagnosed 164 episodes of ASB (33 episodes in the lactoferrin group versus 131 episodes in the control group) and 46 episodes of acute cystitis (4 episodes in the lactoferrin group versus 42 episodes in the control group) were diagnosed. These results were statistically significant (P < 0.00001). No episodes of pyelonephritis were observed in our study cohort. Escherichia coli (E. coli) was the most prevalent isolated organism, accounting for 27% of the ASB episodes in the lactoferrin group and 51% of the ASB episodes in the control group. Similarly, E. coli was isolated in 25% of acute cystitis episodes in the Lf group and 45.2% in the control group. In the exposed group, Lf reduced the risk of both ASB and acute cystitis by 75% and 90%, respectively.

Conclusion: Findings of this study suggest that Lf may play an important preventive role against asymptomatic bacteriuria and symptomatic urinary tract infections in pregnant women. Further multicenter studies on a larger number of patients are needed to improve the generalizability of the results.

Keywords: Lactoferrin; Pregnancy; Prevention; Urinary tract infections.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was ethically approved from the ethical committee of the Faculty of Medicine, Alexandria University (IRB No: 00012098, Approval No: 0107712, on 14th May 2023). The study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from each participant before enrolling in this study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study
Fig. 2
Fig. 2
Incidence of ASB in both groups throughout the study period
Fig. 3
Fig. 3
Incidence of acute cystitis in both groups throughout the study period
Fig. 4
Fig. 4
Trends of negative cultures across the study period in both groups
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Salari N, Khoshbakht Y, Hemmati M, Khodayari Y, Khaleghi AA, Jafari F, Shohaimi S, Mohammadi M. Global prevalence of urinary tract infection in pregnant mothers: a systematic review and meta-analysis. Public Health. 2023;224:58–65. - PubMed
    1. Bhargava K, Nath G, Bhargava A, Kumari R, Aseri GK, Jain N. Bacterial profile and antibiotic susceptibility pattern of uropathogens causing urinary tract infection in the eastern part of Northern India. Front Microbiol. 2022;13: 965053. - PMC - PubMed
    1. Abdel-Aziz Elzayat M, Barnett-Vanes A, Dabour MF, Cheng F. Prevalence of undiagnosed asymptomatic bacteriuria and associated risk factors during pregnancy: a cross-sectional study at two tertiary centres in Cairo Egypt. BMJ Open. 2017;7(3):e013198. - PMC - PubMed
    1. Mohamed NR, Omar HH, Abd-Allah IM. Prevalence and risk factors of urinary tract infection among pregnant women in Ismailia City. Egypt IOSR J Nurs Health Sci. 2017;6(3):62–72.
    1. Ali AH, Reda DY, Ormago MD. Prevalence and antimicrobial susceptibility pattern of urinary tract infection among pregnant women attending Hargeisa Group Hospital, Hargeisa, Somaliland. Sci Rep. 2022;12(1):1419. - PMC - PubMed

Publication types

LinkOut - more resources