Status:
RECRUITING
The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement
Lead Sponsor:
TCI Co., Ltd.
Conditions:
Constipation
Intestinal Functional Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.
Eligibility Criteria
Inclusion
- Male or non-pregnant female subjects aged 18 to 65 who are willing to sign the informed consent form;
- Diagnosed with functional constipation as assessed by a physician;
- Non-pregnant females who agree to use physical contraceptive methods during the study period (e.g., condoms, intrauterine devices);
- No history of organ transplantation, epilepsy or seizures, liver or kidney disease, malignancy, psychiatric disorders, alcohol or drug abuse, or other major organic diseases (as determined by medical history).
Exclusion
- Use of probiotics, gastrointestinal health supplements, medications, or antibiotics within 30 days prior to the study;
- Presence of chronic gastrointestinal diseases (e.g., irritable bowel syndrome \[IBS\], inflammatory bowel disease \[IBD\], Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcers, colorectal cancer, short bowel syndrome, ulcerative colitis);
- History of gastrointestinal or major surgery;
- Lactose intolerance;
- Chronic diarrhea;
- Pregnant or breastfeeding women;
- Known allergy to any components of the study product.
Key Trial Info
Start Date :
August 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07135362
Start Date
August 11 2025
End Date
July 31 2026
Last Update
August 22 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100