Probiotic Improve Constipation

NCT07462481 | Recruiting

• 1 other identifier: WK20260305
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Improvement of constipation symptoms

  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).

  8 weeks

Study Arms (3)

Probiotic Group

EXPERIMENTAL

Taking 60 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products.

Dietary Supplement: Placebo

High-activity probiotic group

EXPERIMENTAL

Taking 300 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.

Dietary Supplement: High-activity probiotic probiotic

Interventions

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.

High-activity probiotic group

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.

Probiotic Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Ying Jin

CONTACT

18336086291; 1959643812@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)