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NCT Number: NCT06847919

Exploring the Potential Benefits of Probiotic Yogurt

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.

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Key information

Conditions

Chronic Constipation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Suzhou, Jiangsu, 215200, China

Location status: Recruiting

Location contact

Ying Jin, Doctor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

  • 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 -

Treatment and study plan

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).

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).

Primary outcomes

  1. Constipation symptom improvement

    Time frame: 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:

    • 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.

Secondary outcomes

  1. Gut microbiota composition and diversity

    Time frame: 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.

  2. Emotional state changes

    Time frame: 3 weeks

    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. Emotional state changes

    Time frame: 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.

  4. Weight management impact

    Time frame: 3 weeks

    Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Jin, Doctor

CONTACT

[email protected]

13375163966

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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