Exploring the Potential Benefits of Probiotic Yogurt

Exploring the Potential Benefits of High-activity Probiotic Yogurt: a Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Constipation
• Intervention / Treatment: Dietary supplement: Probiotic yogurt group; Dietary supplement: Yogurt control group

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Jin, Doctor; Phone Number: 13375163966; Email: sunny13211@sina.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215200
      • Recruiting
      • Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University
      • Contact: Ying Jin, Doctor; Email: sunny13211@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic group; Bacterial count: ≥1000 billion CFUs per bottle Take one bottle of yogurt per day for 3 weeks	Dietary supplement: 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).
Placebo Comparator: Placebo group; Product name: placebo yogurt Take one bottle of yogurt per day for 3 weeks	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation symptom improvement	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: Separate hard lumps, like nuts (difficult to pass); Sausage-shaped but lumpy; Like a sausage but with cracks on the surface; Like a sausage or snake, smooth and soft; Soft blobs with clear-cut edges (passed easily); Fluffy pieces with ragged edges, a mushy stool; 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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota composition and diversity	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.	3 weeks
Emotional state changes	Hospital Anxiety and Depression Scale (HADS) The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in participants' emotional state during the study period. The HADS consists of two subscales: one for anxiety (HADS-A) and one for depression (HADS-D), each containing 7 items. Scoring Range: Each subscale is scored from 0 to 21. Interpretation: Higher scores indicate greater levels of anxiety or depression.	3 weeks
Emotional state changes	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.	3 weeks
Weight management impact	Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight.	3 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: WK20250207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No