The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement

NCT07135362 | Recruiting

• 1 other identifier: 202409097RSE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Intestinal Functional Disorder

Keywords

Bifidobacterium animalis subsp. lactis

Outcome Measures

Primary Outcomes (2)

• The change of stool form

  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).

  Week 0 (Baseline), Week 2, Week 4

• The change of bowel movement and gastrointestinal discomforts

  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.

  Week 0 (Baseline), Week 2, Week 4

Secondary Outcomes (9)

• The change of intestinal microbiota

  Week 0 (Baseline), Week 4

• The change of serum Interleukin-6 level

  Week 0 (Baseline), Week 4

• The change of serum Interleukin-8 level

  Week 0 (Baseline), Week 4

• The change of serum Interleukin-10 level

  Week 0 (Baseline), Week 4

• The change of serum Interleukin-17A level

  Week 0 (Baseline), Week 4

Other Outcomes (15)

• The change of Body weight

  Week 0 (Baseline), Week 4

• The change of Body Mass Index

  Week 0 (Baseline), Week 4

• The change of Percent Body Fat

  Week 0 (Baseline), Week 4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks

Dietary Supplement: Placebo

TCI604 probiotics

EXPERIMENTAL

Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks

Dietary Supplement: TCI604 probiotics

Interventions

TCI604 probiotics DIETARY_SUPPLEMENT

TCI604 probiotics sachet

Also known as: Bifidobacterium animalis subsp. lactis TCI604

TCI604 probiotics

Placebo DIETARY_SUPPLEMENT

Placebo sachet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaw-Shiun Tsai, Doctor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Lin, Ms.

CONTACT

+886-87977811; candice.lin@tci-bio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

TW (1)