RecruitingNot ApplicableNCT06847919

Exploring the Potential Benefits of Probiotic Yogurt

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


Sponsor

Wecare Probiotics Co., Ltd.

Enrollment

84 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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 -

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Interventions

DIETARY_SUPPLEMENTProbiotic 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).

DIETARY_SUPPLEMENTYogurt 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).


Locations(1)

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

Suzhou, Jiangsu, China

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NCT06847919


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