Probiotic to ease chronic constipation

Safety and Efficacy of Lactobacillus Plantarum in Improving Constipation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

This trial will test whether a daily probiotic supplement helps adults with chronic constipation have more regular bowel movements compared with a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07462481 on ClinicalTrials.gov

What this trial studies

Adults aged 18–65 with chronic constipation (fewer than 3 bowel movements per week and/or Bristol Stool Scale types 1–2) will be enrolled and receive either an oral probiotic supplement or a matching placebo. Participants must be able to follow the protocol and agree to the contraception requirements during the study period. Outcomes will focus on changes in bowel habits and safety/tolerability of the probiotic when used as a food supplement. The trial is sponsored by Wecare Probiotics Co., Ltd. and conducted at Suzhou Ninth People's Hospital in Suzhou, Jiangsu.

Who should consider this trial

Good fit: Adults 18–65 with chronic constipation (under 3 bowel movements per week and/or Bristol types 1–2) who can follow the protocol, provide informed consent, and agree to the study contraception rules are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have severe organ disease or immunodeficiency, have recently used similar probiotic products, or who change their diet during the study are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the probiotic could increase bowel movement frequency and improve stool consistency for adults with chronic constipation.

How similar studies have performed: Previous randomized trials and meta-analyses have shown that some probiotic strains can modestly improve bowel frequency and stool consistency in chronic constipation, though results vary by strain and dose.

Eligibility criteria

Inclusion Criteria:

(1) Age 18-65 years; (2) Constipated patients (less than 3 bowel movements per week and/or Bristol Scale type 1 and 2); (3) Able to complete the study according to the trial protocol; (4) Patients who have signed the informed consent form; (5) Study participants (including male study participants) have no plans to have children within 14 days prior to screening and within 6 months after the end of the trial and voluntarily use effective contraception.

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Exclusion Criteria:

1. Those who have taken a substance with a similar function to the test subject in a short period of time, affecting their judgment of the results;
2. Patients who changed their diet during the study;
3. Patients with severe allergies and immunodeficiency;
4. Pregnant, breastfeeding, or women planning to become pregnant;
5. Those with severe diseases of vital organs such as the cardiovascular system, lungs, liver, and kidneys, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, or severe immune system diseases;
6. Those who have used antibiotics in the past two weeks;
7. Those with severe psychological or mental illnesses;
8. Those who did not consume the test sample as required or did not follow up on time, resulting in the inability to determine the efficacy;
9. Other study participants deemed unsuitable by the researchers. -

Where this trial is running

Suzhou, Jiangsu

• Suzhou Ninth People's Hospital — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Ying Jin

Conditions Constipation