The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement

Not Applicable

Recruiting

• Conditions: Constipation; Intestinal Functional Disorder

• Registration Number: NCT07135362
• Lead Sponsor: TCI Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study Start: 2025-08-11
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change of stool form	Week 0 (Baseline), Week 2, Week 4	The stool type will be assessed by The Bristol Stool Form Scale (BSFS). The BSFS is a scale that classifies stools, ranging from the hardest (type 1) to the softest (type 7).
The change of bowel movement and gastrointestinal discomforts	Week 0 (Baseline), Week 2, Week 4	The Gastrointestinal Symptom Rating Scale (GSRS) will be utilized to assess the bowel movement and gastrointestinal discomforts. The GSRS consists of 15 items, each rated on a 7-point Likert scale. A higher score indicates more severe and frequent symptoms.The total GSRS score is calculated by taking the average score of the five symptom categories- Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation- summing them up, and then dividing the total by five to obtain the overall mean score.

Secondary Outcome Measures

Name	Time	Method
The change of intestinal microbiota	Week 0 (Baseline), Week 4	Collect participant's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS).
The change of serum Interleukin-6 level	Week 0 (Baseline), Week 4	A fasting blood sample will be collected for Interleukin-6 (IL-6) testing using an Enzyme-Linked Immunosorbent Assay kit.
The change of serum Interleukin-8 level	Week 0 (Baseline), Week 4	A fasting blood sample will be collected for Interleukin-8 (IL-8) testing using an Enzyme-Linked Immunosorbent Assay kit.
The change of serum Interleukin-10 level	Week 0 (Baseline), Week 4	A fasting blood sample will be collected for Interleukin-10 (IL-10) testing using an Enzyme-Linked Immunosorbent Assay kit.
The change of serum Interleukin-17A level	Week 0 (Baseline), Week 4	A fasting blood sample will be collected for Interleukin-17A (IL-17A) testing using an Enzyme-Linked Immunosorbent Assay kit.
The change of blood High-sensitivity C-Reactive Protein level	Week 0 (Baseline), Week 4	Venous blood samples will be collected to measure concentrations of High-sensitivity C-Reactive Protein.
The change of serum Lipopolysaccharide binding protein level	Week 0 (Baseline), Week 4	A fasting blood sample will be collected for Lipopolysaccharide testing using an Enzyme-Linked Immunosorbent Assay kit.
The change of serum neopterin level	Week 0 (Baseline), Week 4	A fasting blood sample will be collected for neopterin testing using an Enzyme-Linked Immunosorbent Assay kit.
The change of intestinal fecal loading	Week 0 (Baseline), Week 4	Intestinal fecal loading will be evaluated using abdominal X-ray imaging.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan