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NCT Number: NCT07135362

The Efficacy Evaluation of 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.

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Key information

Conditions

Constipation Intestinal Functional Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Jaw-Shiun Tsai, Doctor

CONTACT

+886-23123456

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCI604 probiotics

Dietary Supplement

TCI604 probiotics sachet

Other names: Bifidobacterium animalis subsp. lactis TCI604

Placebo

Dietary Supplement

Placebo sachet

Primary outcomes

  1. The change of stool form

    Time frame: 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).

  2. The change of bowel movement and gastrointestinal discomforts

    Time frame: 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 outcomes

  1. The change of intestinal microbiota

    Time frame: Week 0 (Baseline), Week 4

    Collect participant's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS).

  2. The change of serum Interleukin-6 level

    Time frame: 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.

  3. The change of serum Interleukin-8 level

    Time frame: 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.

  4. The change of serum Interleukin-10 level

    Time frame: 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.

  5. The change of serum Interleukin-17A level

    Time frame: 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.

  6. The change of blood High-sensitivity C-Reactive Protein level

    Time frame: Week 0 (Baseline), Week 4

    Venous blood samples will be collected to measure concentrations of High-sensitivity C-Reactive Protein.

  7. The change of serum Lipopolysaccharide binding protein level

    Time frame: Week 0 (Baseline), Week 4

    A fasting blood sample will be collected for Lipopolysaccharide testing using an Enzyme-Linked Immunosorbent Assay kit.

  8. The change of serum neopterin level

    Time frame: Week 0 (Baseline), Week 4

    A fasting blood sample will be collected for neopterin testing using an Enzyme-Linked Immunosorbent Assay kit.

  9. The change of intestinal fecal loading

    Time frame: Week 0 (Baseline), Week 4

    Intestinal fecal loading will be evaluated using abdominal X-ray imaging.

Other outcomes

  1. The change of Body weight

    Time frame: Week 0 (Baseline), Week 4

    Body weight will be assessed by Body Composition Analyzer. Unit: kg

  2. The change of Body Mass Index

    Time frame: Week 0 (Baseline), Week 4

    Body Mass Index (BMI) level will be assessed by Body Composition Analyzer. Unit: kg/cm^2

  3. The change of Percent Body Fat

    Time frame: Week 0 (Baseline), Week 4

    Percent Body Fat will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: Percent

  4. The change of Visceral Fat Level

    Time frame: Week 0 (Baseline), Week 4

    Visceral Fat Level will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: arbitrary unit

  5. The change of waist and hip circumference

    Time frame: Week 0 (Baseline), Week 4

    Waist and hip circumference will be assessed by measuring tape.

  6. The change of blood pressure

    Time frame: Week 0 (Baseline), Week 4

    Systolic pressure and diastolic pressure will be assessed by sphygmomanometer.

  7. The change of blood lipids profiles

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure concentrations of total cholesterol, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, and triglyceride.

  8. The change of blood liver function biomarkers (AST, ALT)

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure concentrations of liver function biomarkers.

  9. The change of blood renal function biomarkers (creatinine, BUN)

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure concentrations of renal function biomarkers.

  10. The change of blood fasting glucose level

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure concentrations of fasting glucose level.

  11. The change of blood cells counts

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure the blood cells counts, including white blood cell (WBC) count/automated differential, red blood cell (RBC) count, platelet count. Unit: count/uL

  12. The change of hemoglobin

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure the hemoglobin. Unit: g/dL

  13. The change of hematocrit

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure the hematocrit. Unit: %

  14. The change of mean corpuscular volume

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure the mean corpuscular volume (M.C.V). Unit: fl

  15. The change of mean corpuscular hemoglobin concentration

    Time frame: Week 0 (Baseline), Week 4

    Venous blood will be sampled to measure the mean corpuscular hemoglobin concentration (M.C.H.C). Unit: g/dL

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Lin, Ms.

CONTACT

[email protected]

+886-87977811

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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