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Efficacy of Probiotics for OAB Patients With Anxiety

NCT07635212 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-06-09

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if probiotics can help improve symptoms in adults with overactive bladder (OAB) and anxiety. The main questions it aims to answer are:

1. Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?
2. Does taking probiotics lower participants' anxiety levels?

Researchers will compare probiotics to a placebo (a look-alike powder that contains no active bacteria) to see if the probiotics work better to treat OAB and anxiety when both groups also use standard behavioral therapy (like bladder training).

Participants will:

1. Take probiotics or a placebo twice a day for 12 weeks.
2. Learn and practice bladder training using a manual and educational videos.
3. Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.
4. Answer survey questions about their anxiety and quality of life during clinic visits.
5. Provide urine samples for routine checkups to ensure they do not have infections.

Conditions

  • Overactive Bladder (OAB)

Interventions

DIETARY_SUPPLEMENT

Multi-strain Probiotic Compound

The active intervention consists of a probiotic powder containing Lactobacillus plantarum DY-1, Lactobacillus casei KDB-LC, and Lactobacillus acidophilus KDB-03. The powder is to be dissolved in a glass of water and administered orally once a day for 12 weeks.

OTHER

Placebo

An inactive placebo powder composed of inert excipients (maltodextrin) containing no active bacteria. It is visually and organoleptically identical to the active probiotic product (matching in color, texture, taste, and solubility). The powder is to be dissolved in a glass of water and administered orally once a day for 12 weeks.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Yuchao Sun, Bachelor · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635212 on ClinicalTrials.gov