Recruiting NCT07135362

The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement

No phase Interventional Constipation Intestinal Functional Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: TCI604 probiotics, Placebo.
Who it may be relevant to: Registry conditions: Constipation, Intestinal Functional Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Taiwan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

The change of stool form [Time frame: Week 0 (Baseline), Week 2, Week 4]
The change of bowel movement and gastrointestinal discomforts [Time frame: Week 0 (Baseline), Week 2, Week 4]

Secondary outcome measures (9)

The change of intestinal microbiota [Time frame: Week 0 (Baseline), Week 4]
The change of serum Interleukin-6 level [Time frame: Week 0 (Baseline), Week 4]
The change of serum Interleukin-8 level [Time frame: Week 0 (Baseline), Week 4]
The change of serum Interleukin-10 level [Time frame: Week 0 (Baseline), Week 4]
The change of serum Interleukin-17A level [Time frame: Week 0 (Baseline), Week 4]
The change of blood High-sensitivity C-Reactive Protein level [Time frame: Week 0 (Baseline), Week 4]
The change of serum Lipopolysaccharide binding protein level [Time frame: Week 0 (Baseline), Week 4]
The change of serum neopterin level [Time frame: Week 0 (Baseline), Week 4]
The change of intestinal fecal loading [Time frame: Week 0 (Baseline), Week 4]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Taiwan · 1 center

NCT: NCT07135362 · 202409097RSE