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NCT Number: NCT06761443

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location status: Recruiting

Location contact

Yuhan xia, Doctor

CONTACT

[email protected]

18336086291

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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 criteria

  • 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. -

Treatment and study plan

Probiotic

Dietary Supplement

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

Maltodextrin

Dietary Supplement

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

Primary outcomes

  1. Constipation symptom improvement

    Time frame: 8 weeks

    Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics.

Study contacts

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

Yuhan xia, Doctor

CONTACT

[email protected]

18336086291

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 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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