Actively Recruiting
Study to Evaluate Safety and Effects of Pediococcus acidilactici PA53 Probiotic in Adults with Constipation Randomized, Double-blind, Placebo-controlled Trial
Led by Wecare Probiotics Co., Ltd. · Updated on 2025-01-07
10
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Pediococcus acidilactici PA53, a probiotic, on adults with constipation. The study aims to assess improvements in constipation symptoms, quality of life, mental state, intestinal function, intestinal hormones, inflammation, immunity, and intestinal flora after an 8-week intervention period. This randomized, double-blind, placebo-controlled trial focuses on adults aged 18 to 70 years who experience constipation defined as fewer than three bowel movements per week and/or specific stool types. Participants will be randomly assigned to receive either the probiotic Pediococcus acidilactici PA53 or a placebo containing maltodextrin. The experimental phase lasts 8 weeks, during which each participant will attend three visits at week 0, week 4, and week 8. Both treatments are administered as dietary supplements, and adherence to the dosing schedule is monitored throughout the study. During the study, participants will be assessed at each visit for changes in constipation symptoms and other health parameters related to intestinal and immune function. Researchers will measure constipation symptom improvement as the primary outcome after 8 weeks. Participants' ability to complete the study according to the plan and adherence to study requirements are monitored. Safety and efficacy data will be collected to evaluate the probiotic's impact compared to placebo.
CONDITIONS
Official Title
To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Constipated subjects with fewer than 3 bowel movements per week and/or Bristol Scale Types 1 and 2
- Able to complete the study according to the test plan requirements
- Signed informed consent
- Male subjects with no family planning and willing to use effective contraception from 14 days before screening to 6 months after the trial ends
You will not qualify if you...
- Short-term use of similar functional items affecting study results
- Changed diet type during the study period
- Severe allergies or immune deficiencies
- Women who are pregnant, breastfeeding, or planning pregnancy
- Serious diseases of heart, lung, liver, kidney, diabetes, thyroid, severe metabolic diseases, malignant tumors, or severe immune diseases
- Used antibiotics within the past two weeks
- Serious mental illness
- Failure to eat the test sample as required or failure to follow up on time
- Judged inappropriate to participate by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Nutrition, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Actively Recruiting
Research Team
Y
Yuhan xia, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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