TCI604 probiotic to improve intestinal function

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

This trial will test whether the TCI604 probiotic can improve gut function and relieve constipation in adults with functional constipation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: TCI Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT07135362 on ClinicalTrials.gov

What this trial studies

Adults aged 18–65 diagnosed with functional constipation will be assigned to receive either the TCI604 probiotic (containing Bifidobacterium animalis subsp. lactis) or a matching placebo. Participants with recent probiotic or antibiotic use, chronic gastrointestinal diseases, or major organ or psychiatric conditions are excluded. The intervention is administered at National Taiwan University Hospital with clinical follow-up and symptom monitoring over the treatment period. Outcomes will focus on changes in intestinal function and constipation-related symptoms compared between the probiotic and placebo groups.

Who should consider this trial

Good fit: Adults 18–65 with physician-diagnosed functional constipation who are non-pregnant and without major organ disease and who have not used probiotics or antibiotics in the prior 30 days.

Not a fit: Patients with chronic GI diseases (for example IBS, IBD, Crohn's disease, or ulcerative colitis), recent antibiotic or probiotic use, or significant organ or psychiatric illness are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, TCI604 could provide a safe, easy probiotic option to increase stool frequency and ease constipation symptoms.

How similar studies have performed: Prior randomized studies of Bifidobacterium animalis subsp. lactis and related probiotics have shown modest improvements in stool frequency and consistency, but results vary by strain and patient population.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Jaw-Shiun Tsai, Doctor — National Taiwan University Hospital
• Study coordinator: Ping Lin, Ms.

Conditions Constipation; Intestinal Functional Disorder; Bifidobacterium animalis subsp. lactis