RecruitingNot ApplicableNCT07135362

The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement

The Efficacy Evaluation of Bifidobacterium Animalis Subsp. Lactis TCI604 Probiotic on Intestinal Function Improvement

Sponsor

TCI Co., Ltd.

Enrollment

60 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.

Min Age: 18 YearsMax Age: 65 Years

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).

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.