Probiotic Improve Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo, High-activity probiotic probiotic.
- Who it may be relevant to
- Registry conditions: Constipation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Probiotics in Relieving Constipation in Adults
Overview
To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.
Interventions
- Dietary supplement Probiotic
The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. - Dietary supplement Placebo
The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. - Dietary supplement High-activity probiotic probiotic
The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.
Primary outcome measures
- Improvement of constipation symptoms [Time frame: 8 weeks]
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
- 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;
- Patients who changed their diet during the study;
- Patients with severe allergies and immunodeficiency;
- Pregnant, breastfeeding, or women planning to become pregnant;
- 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;
- Those who have used antibiotics in the past two weeks;
- Those with severe psychological or mental illnesses;
- 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;
- Other study participants deemed unsuitable by the researchers. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Suzhou Ninth People's Hospital — Suzhou
Identifiers
NCT: NCT07462481 · WK20260305