Probiotics vs. placebo for adults with 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

This randomized, double-blind, placebo-controlled trial will compare probiotic supplementation to placebo for 8 weeks in adults with functional constipation. Outcomes include changes in bowel habits, symptom burden, and several physiological markers such as inflammation, immune modulation, gut microbiota, gut-brain axis signaling, and metabolic responses. The study aims to characterize the overall physiological impact of probiotic use in this population. Eligible participants are adults 18–65 with infrequent bowel movements or hard stools, who can comply with the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women aged between 18 and 65 years;
2. Participants presenting with constipation, characterized by \<3 spontaneous bowel movements per week or BSFS stool types 1-2;
3. Capable of following the study protocol and completing all required assessments; Individuals who have voluntarily signed the informed consent form;
4. No plans for pregnancy from at least 14 days prior to screening through 6 months after the study, with agreement to use reliable contraception methods.

Exclusion Criteria:

1. Intake of similar functional products within a short period prior to enrollment that could influence study results;
2. Participants who significantly alter their habitual diet during the trial;
3. Individuals with severe allergic conditions or impaired immune function;
4. Women who are pregnant, lactating, or intending to conceive;
5. Patients with serious underlying diseases affecting major organs or metabolic systems;
6. Antibiotic treatment within 2 weeks before enrollment;
7. Individuals with severe mental or psychological disorders;
8. Non-compliance with study requirements, including improper intake or missed follow-ups;
9. Other subjects considered inappropriate for participation by the investigator.

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

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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.