RecruitingNot ApplicableNCT06761443

To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults

Based on a Randomized, Double-blind, Placebo-controlled Trial, we Evaluated the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults


Sponsor

Wecare Probiotics Co., Ltd.

Enrollment

10 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • \. Constipated subjects Subjects (less than 3 bowel movements per week and/or Bristol Scale Types 1 and 2); 2. Be able to complete the research according to the requirements of the test plan; 3. Subjects who have signed informed consent; 4. Subjects (including male subjects) have no family planning and voluntarily take effective contraceptive measures from 14 days before screening to 6 months after the end of the trial.
  • \-

Exclusion Criteria9

  • Short-term use of items with similar functions to the subject, which affects the judge of the result;
  • Those who changed their diet type during the study period;
  • People with severe allergies and immune deficiencies;
  • Women who are pregnant, breastfeeding or planning to become pregnant;
  • Patients with serious diseases of cardiovascular, lung, liver, kidney and other vital organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
  • People who have used antibiotics in the past two weeks;
  • People with serious mental and mental illness;
  • Failure to eat the test sample as required, or failure to follow up on time, resulting in uncertain efficacy;
  • Other researchers judged it inappropriate to participate. -

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Interventions

DIETARY_SUPPLEMENTProbiotic

The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

DIETARY_SUPPLEMENTMaltodextrin

The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).


Locations(1)

Department of Nutrition, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

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NCT06761443


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