Constipation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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_SUPPLEMENTPlacebo
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_SUPPLEMENTHigh-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.
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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. \-
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
CONTACTYing Jin
Outcome results
None listed