## Protocol Section
### Identification Module
**NCT ID:** NCT06429358

**Brief Title:** The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women

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

#### Organization Study ID Info
**ID:** 3388
#### Organization
**Class:** OTHER
**Full Name:** Frontier Medical and Dental College, Abbotabad
### Status Module
#### Completion Date
**Date:** 2024-01-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-14

**Type:** ACTUAL

#### Start Date
**Date:** 2023-06-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Frontier Medical and Dental College, Abbotabad

#### Responsible Party

**Investigator Affiliation:** Frontier Medical and Dental College, Abbotabad

**Investigator Full Name:** Dr Saif ur Rehman

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Urinary Tract Infections

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomised Controlled Trial

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: Lactobacillus rhamnosus

**Label:** Probiotic Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Control Group

**Label:** Control Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Probiotic Group

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

**Name:** Lactobacillus rhamnosus

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Control Group

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

**Name:** Control Group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The test was performed to determine levels of neutrophils

**Measure:** 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.

**Description:** 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

**Measure:** 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.

**Description:** leukocytes in urine were evaluated

**Measure:** Leukocytes:

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

**Description:** presence of nitrites in urine before and after intervention was investigated

**Measure:** Nitrites:

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

**Description:** Urinary pH values were measured

**Measure:** pH

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

### Eligibility Module

**Eligibility Criteria:** 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.

**Gender Based:** True

**Gender Description:** 14 week's gestation with diagnosed UTI

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Abbottābād

**Country:** Pakistan

**Facility:** Frontier Medical and Dental College

**State:** KPK

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M17302

- Name: Urinary Tract Infections

- Relevance: HIGH

- As Found: Urinary Tract Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000014552

- Term: Urinary Tract Infections

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T355

- Name: Acidophilus

- Relevance: HIGH

- As Found: Students

### Misc Info Module

- Version Holder: 2024-05-31
