Exploring the Potential Benefits of Probiotic Yogurt

Not Applicable

Recruiting

• Conditions: Chronic Constipation

• Registration Number: NCT06847919
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-21
• Study Start: 2025-02-25
• Study First Posted: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Constipation symptom improvement	3 weeks	The Bristol Stool Form Scale (BSFS) will be used to assess improvements in constipation. The BSFS is a 9-point scale ranging from 1 to 7, where higher scores indicate softer stool consistency, approaching a liquid state. The specific scoring is as follows: 1. Separate hard lumps, like nuts (difficult to pass); 2. Sausage-shaped but lumpy; 3. Like a sausage but with cracks on the surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear-cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces, entirely liquid Scores of 4, 5, and 6 are generally considered ideal, indicating smooth bowel movements without constipation.; Therefore, higher scores (closer to 4-6) represent improved constipation symptoms, while lower scores (1-3) indicate more severe constipation.

Secondary Outcome Measures

Name	Time	Method
Gut microbiota composition and diversity	3 weeks	Evaluating the changes in the composition and diversity of the gut microbiota before and after the intake of probiotic yogurt using high-throughput sequencing technology.
Emotional state changes	3 weeks	Depression Anxiety Stress Scales (DASS) The Depression Anxiety Stress Scales (DASS) will be used to assess changes in participants' emotional state during the study period. The DASS includes three subscales: Depression (DASS-D), Anxiety (DASS-A), and Stress (DASS-S), each containing 14 items.; Scoring Range: Each subscale is scored from 0 to 42. Interpretation: Higher scores indicate greater levels of depression, anxiety, or stress.
Weight management impact	3 weeks	Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight.

Trial Locations

Locations (1)

Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University; 🇨🇳 Suzhou, Jiangsu, China