Probiotic to ease chronic constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Suzhou Ninth People's Hospital
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Ying Jin
• Email: 1959643812@qq.com
• Phone: 18336086291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.