Using probiotics to relieve chronic constipation in adults

Assessing the Safety and Effectiveness of Weizmania Coagulant BC99 in Relieving Functional Constipation in Adults Based on Randomized, Double-Blind, Placebo-Controlled Trials

This study tests if taking probiotics can help adults with chronic constipation feel better and improve their gut health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Luoyang, He Nan and 1 other locations)
• Trial ID: NCT06637397 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of probiotics on alleviating chronic constipation in adults aged 18 to 70 who meet specific diagnostic criteria. Participants will receive either probiotics or a placebo to evaluate improvements in their constipation symptoms, gastrointestinal function, immunity, and gut microbiota. The study aims to provide insights into the efficacy of probiotics as a treatment option for chronic constipation.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 to 70 with chronic constipation lasting over six months.

Not a fit: Patients with severe allergies, immune deficiencies, or those who have recently altered their diet may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new, effective treatment option for adults suffering from chronic constipation.

How similar studies have performed: Previous studies have shown promising results for probiotics in managing gastrointestinal issues, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Chinese adults who meet the diagnostic criteria of Rome III, aged between 18 and 70;
2. Patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or Bristol stool form scale types 1 and 2);
3. Able to complete the study according to the requirements of the experimental protocol;
4. Patients who have signed the informed consent form;
5. Research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily.

Exclusion Criteria:

1. Individuals who have taken items with similar functions to the tested product within a short period of time, which may affect the judgment of the results;
2. Patients who have changed their diet during the study period;
3. Patients with severe allergies and immune deficiencies;
4. Female patients who are pregnant, breastfeeding, or have plans to become pregnant;
5. Patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases;
6. Individuals who have used antibiotics within the past two weeks;
7. Individuals with severe psychological or mental illnesses;
8. Participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness;
9. Other research participants deemed unsuitable for participation by the researchers.

Where this trial is running

Luoyang, He Nan and 1 other locations

• The School of Food and Bioengineering, Henan University of Science and Technolog — Luoyang, He Nan, China (Recruiting)
• Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)

Study contacts

• Study coordinator: Ying Wu

Conditions Constipation