The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTCI Co., Ltd.
About this trial
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
Qualifiers
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).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- TCI604 probiotics
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov