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
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2025
CompletedStudy Start
First participant enrolled
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2025
CompletedJanuary 7, 2025
January 1, 2025
2 months
January 1, 2025
January 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Constipation symptom improvement
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.
8 weeks
Study Arms (2)
Probiotic
EXPERIMENTALEvery day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks. Store in a cool and dry place.
Placebo
PLACEBO COMPARATOREvery day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
Interventions
The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).
The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2025
First Posted
January 7, 2025
Study Start
February 25, 2025
Primary Completion
April 25, 2025
Study Completion
May 25, 2025
Last Updated
January 7, 2025
Record last verified: 2025-01