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Completed

NCT Number: NCT06429358

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Frontier Medical and Dental College

Abbottābād, KPK, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus rhamnosus

Dietary Supplement

The probiotic supplement was delivered in the form of easy-to-swallow capsules.

Control Group

Other

Participants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill.

Primary outcomes

  1. Urinary Detailed Report Values

    Time frame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

    The test was performed to determine levels of neutrophils

  2. Urine Culture

    Time frame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

    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

  3. Leukocytes:

    Time frame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

    leukocytes in urine were evaluated

  4. Nitrites:

    Time frame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

    presence of nitrites in urine before and after intervention was investigated

  5. pH

    Time frame: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

    Urinary pH values were measured

Sponsors and collaborators

Lead sponsor

Frontier Medical and Dental College, Abbotabad

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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