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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06429358
• Other study ID #: 3388
• Status: Completed
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: May 2024
• Source: Frontier Medical and Dental College, Abbotabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 15, 2024
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus
The probiotic supplement was delivered in the form of easy-to-swallow capsules.

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

Locations

Country	Name	City	State
Pakistan	Frontier Medical and Dental College	Abbottabad	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Frontier Medical and Dental College, Abbotabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.