Probiotics for Alleviating Functional Constipation in Adults

Not Applicable

Recruiting

• Conditions: Constipation

• Registration Number: NCT06637397
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-27
• Study Start: 2024-05-30
• Primary Completion: 2024-08-30
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Chinese adults who meet the diagnostic criteria of Rome III, aged between 18 and 70;
2. Patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or Bristol stool form scale types 1 and 2);
3. Able to complete the study according to the requirements of the experimental protocol;
4. Patients who have signed the informed consent form;
5. Research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily.

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Exclusion Criteria

1. Individuals who have taken items with similar functions to the tested product within a short period of time, which may affect the judgment of the results;
2. Patients who have changed their diet during the study period;
3. Patients with severe allergies and immune deficiencies;
4. Female patients who are pregnant, breastfeeding, or have plans to become pregnant;
5. Patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases;
6. Individuals who have used antibiotics within the past two weeks;
7. Individuals with severe psychological or mental illnesses;
8. Participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness;
9. Other research participants deemed unsuitable for participation by the researchers.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.	8 weeks	Constipation symptoms are measured using Bristol Stool Form Scale (BSFS).

Trial Locations

Locations (2)

The School of Food and Bioengineering, Henan University of Science and Technolog; 🇨🇳 Luoyang, He Nan, China

Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China