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RECRUITING

NCT07765004

Probiotics Improve Constipation

Sponsor: Wecare Probiotics Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. Through blood and fecal sample analyses combined with multidimensional questionnaire assessments, the study aims to systematically evaluate the efficacy of probiotics in improving gastrointestinal function, immune status, and mental health in patients with constipation.

Official title: Safety and Efficacy of Probiotics for Constipation Relief in Adults: A Randonmized, Double-blind, Placebo-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-07

Completion Date

2026-12-20

Last Updated

2026-08-17

Healthy Volunteers

Yes

Conditions

Constipation

Interventions

DIETARY_SUPPLEMENT

Probitics

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 1, Week 2, 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 1, Week 2, Week 4, and Week 8.

Inclusion Criteria: * Aged 18 to 65 years (inclusive). * Diagnosed with constipation, defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Scale types 1 or 2. * Willing and able to comply with the study protocol and complete all required assessments. * Provide written informed consent prior to any study-related procedures. * Male and female participants of childbearing potential must agree to use effective contraception voluntarily from 14 days prior to screening until 6 months after the end of the trial. Female participants of non-childbearing potential (e.g., post-menopausal or surgically sterile) are exempt from this requirement. Exclusion Criteria: * Use of products with functions similar to the investigational product within a short period prior to screening that may interfere with the evaluation of study outcomes. * Intention to change dietary habits significantly during the study period. * Severe allergies or immunodeficiency. * Women who are pregnant, breastfeeding, or planning to become pregnant during the trial. * Severe diseases of vital organs (including cardiovascular, pulmonary, hepatic, or renal disease), metabolic diseases (e.g., diabetes, thyroid disorders), malignancy, or severe immune system disorders. * Use of antibiotics within the past 30 days. * Severe psychological or psychiatric disorders. * Poor compliance (e.g., failure to take the test product as instructed or failure to attend scheduled follow-up visits) that would preclude a valid assessment of efficacy. * Organic constipation (e.g., caused by structural or pathological conditions). * Irritable bowel syndrome with constipation (IBS-C). * History of surgical procedures within 30 days prior to screening that may have caused or contributed to constipation symptoms. * Intake of probiotic or prebiotic supplements within one month prior to the start of the study. * Any other condition that, in the investigator's opinion, would make the participant unsuitable for participation in the study.

Locations (1)

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, China