Probiotic Improve Constipation

NCT07462481 — Not applicable, Recruiting, 105 participants, Wecare Probiotics Co., Ltd.

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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Probiotics in Relieving Constipation in Adults

Registry	NCT07462481
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	105 (Estimated)
Sponsor	Wecare Probiotics Co., Ltd. (Industry)
Conditions	Constipation
Interventions	Probiotic, Placebo, High-activity probiotic probiotic (Dietary supplement)
Dates	start 2026-06-10 (estimated), primary completion 2027-06-01 (estimated), completion 2027-08-01 (estimated), first posted 2026-03-10, last updated 2026-06-09
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic Group	Experimental	Dietary Supplement: Probiotic	Taking 60 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.
Placebo Group	Placebo comparator	Dietary Supplement: Placebo	Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products.
High-activity probiotic group	Experimental	Dietary Supplement: High-activity probiotic probiotic	Taking 300 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.

Probiotic (Dietary supplement): 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.
Placebo (Dietary supplement): 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.
High-activity probiotic probiotic (Dietary supplement): 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.

+Outcome measures

Primary outcomes

Improvement of constipation symptoms [8 weeks]: Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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. -

+Locations (1)

Facility	City	Country	Status
Suzhou Ninth People's Hospital	Suzhou, Jiangsu	China	Recruiting