Exploring the Potential Benefits of Probiotic Yogurt

NCT06847919 | Recruiting

• 1 other identifier: WK20250207
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  3 weeks

Secondary Outcomes (4)

• Gut microbiota composition and diversity

  3 weeks

• Emotional state changes

  3 weeks

• Emotional state changes

  3 weeks

• Weight management impact

  3 weeks

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic yogurt group

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Yogurt control group

Interventions

Probiotic yogurt group 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).

Probiotic group

Yogurt control group 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

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

Suzhou, Jiangsu, 215200, China

RECRUITING

Central Study Contacts

Ying Jin, Doctor

CONTACT

13375163966; sunny13211@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 26, 2025
• Study Start: February 25, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

CN (1)