Exploring the Potential Benefits of Probiotic Yogurt

NCT ID: NCT06847919

Last Updated: 2025-03-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2025-12-30

Brief Summary

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This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.

Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotic group

Bacterial count: ≥1000 billion CFUs per bottle Take one bottle of yogurt per day for 3 weeks

Group Type ACTIVE_COMPARATOR

Probiotic yogurt group

Intervention Type DIETARY_SUPPLEMENT

The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).

Placebo group

Product name: placebo yogurt Take one bottle of yogurt per day for 3 weeks

Group Type PLACEBO_COMPARATOR

Yogurt control group

Intervention Type DIETARY_SUPPLEMENT

The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).

Interventions

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Probiotic yogurt group

The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).

Intervention Type DIETARY_SUPPLEMENT

Yogurt control group

The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Meet the Rome IV diagnosis criteria for chronic constipation;
2. Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures;
3. Age 18-65. -

Exclusion Criteria

1. Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota;
2. Patients who are pregnant or lactating;
3. have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks;
4. Patients who changed their diet type during the study;
5. Patients who are allergic or intolerant to any component of the investigational product formulation;
6. Patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases and endocrine diseases, mental patients;
7. Stop taking the tested sample or add other drugs in the middle, unable to judge the efficacy or incomplete data;
8. short-term use of objects related to the function of the test, affecting the judgment of the result;
9. have been dieting, exercising excessively, taking weight loss medications or taking medications that may affect appetite in the past 3 months;
10. Current or past excessive use of alcohol, drugs, or supplements that may cause intestinal dysfunction or interfere with the evaluation of the efficacy of the study product -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Jin, Doctor

Role: CONTACT

13375163966

Facility Contacts

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Ying Jin, Doctor

Role: primary

Other Identifiers

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WK20250207

Identifier Type: -

Identifier Source: org_study_id

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