The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women

The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial

Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Dietary supplement: Lactobacillus rhamnosus; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Abbottābād, KPK, Pakistan
      • Frontier Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant women aged 18-40 year
• History of recurrent urinary tract infections (two or more episodes in the past year).
• Singleton pregnancy.

Exclusion Criteria:

• Multiple gestations.
• History of preterm labor.
• Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
• Use of antibiotics or probiotics within the past month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group	Other: Control Group; Participants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill.
Experimental: Probiotic Group; The probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules.	Dietary supplement: Lactobacillus rhamnosus; The probiotic supplement was delivered in the form of easy-to-swallow capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Detailed Report Values	The test was performed to determine levels of neutrophils	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
Urine Culture	Urine Culture: Urine samples were collected aseptically prior to and after intervention and cultured to detect bacterial pathogens linked with urinary tract infections. This assessment was carried out at two distinct time points: Pre-Intervention: Before beginning the probiotic intervention, baseline urine samples were taken to detect any existing bacterial illnesses and create a point of comparison. Post-Intervention: After the intervention period, individuals supplied an additional urine sample for culture investigation. This post-intervention evaluation sought to establish any changes in the prevalence of bacterial pathogens, particularly those known to cause urinary tract infection	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
Leukocytes:	leukocytes in urine were evaluated	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
Nitrites:	presence of nitrites in urine before and after intervention was investigated	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.
pH	Urinary pH values were measured	second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

Collaborators and Investigators

• Sponsor: Frontier Medical and Dental College, Abbotabad

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 3388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No