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

NCT ID: NCT06429358

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2024-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotic Group

The probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules.

Group Type EXPERIMENTAL

Lactobacillus rhamnosus

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

Group Type OTHER

Control Group

Intervention Type OTHER

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

Interventions

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Lactobacillus rhamnosus

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

Intervention Type DIETARY_SUPPLEMENT

Control Group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Frontier Medical and Dental College, Abbotabad

OTHER

Sponsor Role lead

Responsible Party

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Dr Saif ur Rehman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Frontier Medical and Dental College

Abbottābād, KPK, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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3388

Identifier Type: -

Identifier Source: org_study_id

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