Evaluating a probiotic for 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
This study is testing if a probiotic can help adults with constipation feel better and improve their overall gut health over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Wecare Probiotics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Yinchuan, Ningxia) |
| Trial ID | NCT06761443 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of Pediococcus acidilactici PA53 in alleviating constipation symptoms in adults over an 8-week period. Participants will be monitored for improvements in bowel movement frequency, quality of life, mental state, intestinal function, and changes in intestinal flora and hormones. The intervention involves administering a probiotic alongside maltodextrin to enhance gut health. The study will include regular assessments to evaluate the overall impact on participants' health and well-being.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing constipation, defined as having fewer than three bowel movements per week.
Not a fit: Patients with severe underlying health conditions or those currently using similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new probiotic treatment option for adults suffering from constipation.
How similar studies have performed: Other studies have shown promising results with probiotics for gastrointestinal issues, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. 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: 1. Short-term use of items with similar functions to the subject, which affects the judge of the result; 2. Those who changed their diet type during the study period; 3. People with severe allergies and immune deficiencies; 4. Women who are pregnant, breastfeeding or planning to become pregnant; 5. 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; 6. People who have used antibiotics in the past two weeks; 7. People with serious mental and mental illness; 8. Failure to eat the test sample as required, or failure to follow up on time, resulting in uncertain efficacy; 9. Other researchers judged it inappropriate to participate. -
Where this trial is running
Yinchuan, Ningxia
- Department of Nutrition, General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
Study contacts
- Study coordinator: Yuhan xia, Doctor
- Email: 1959643812@qq.com
- Phone: 18336086291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.