ConstipationNCT07135362
The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement
A study testing TCI604 probiotics in people with Constipation and Intestinal Functional Disorder, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Intestinal Functional Disorder
- What is being tested?
- TCI604 probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jaw-Shiun Tsai, Doctor, +886-23123456
About this study
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.
- Conditions
- Constipation, Intestinal Functional Disorder
- Being tested
- TCI604 probiotics, Placebo
- Keywords
- Bifidobacterium animalis subsp. lactis
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI604 probioticsDietary supplement
Also called Bifidobacterium animalis subsp. lactis TCI604
TCI604 probiotics sachet
PlaceboDietary supplement
Placebo sachet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks Receives: Dietary Supplement: Placebo |
| TCI604 probiotics | Experimental | Taking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks Receives: Dietary Supplement: TCI604 probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Week 0 (Baseline), Week 2, Week 4
Secondary outcomes (9)
The change of intestinal microbiota
Collect participant's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS).
Measured: Week 0 (Baseline), Week 4
The change of serum Interleukin-6 level
A fasting blood sample will be collected for Interleukin-6 (IL-6) testing using an Enzyme-Linked Immunosorbent Assay kit.
Measured: Week 0 (Baseline), Week 4
The change of serum Interleukin-8 level
A fasting blood sample will be collected for Interleukin-8 (IL-8) testing using an Enzyme-Linked Immunosorbent Assay kit.
Measured: Week 0 (Baseline), Week 4
The change of serum Interleukin-10 level
A fasting blood sample will be collected for Interleukin-10 (IL-10) testing using an Enzyme-Linked Immunosorbent Assay kit.
Measured: Week 0 (Baseline), Week 4
The change of serum Interleukin-17A level
A fasting blood sample will be collected for Interleukin-17A (IL-17A) testing using an Enzyme-Linked Immunosorbent Assay kit.
Measured: Week 0 (Baseline), Week 4
The change of blood High-sensitivity C-Reactive Protein level
Venous blood samples will be collected to measure concentrations of High-sensitivity C-Reactive Protein.
Measured: Week 0 (Baseline), Week 4
The change of serum Lipopolysaccharide binding protein level
A fasting blood sample will be collected for Lipopolysaccharide testing using an Enzyme-Linked Immunosorbent Assay kit.
Measured: Week 0 (Baseline), Week 4
The change of serum neopterin level
A fasting blood sample will be collected for neopterin testing using an Enzyme-Linked Immunosorbent Assay kit.
Measured: Week 0 (Baseline), Week 4
The change of intestinal fecal loading
Intestinal fecal loading will be evaluated using abdominal X-ray imaging.
Measured: Week 0 (Baseline), Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start11 Aug 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaw-Shiun Tsai, Doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135362
- Sponsor's protocol ID
- 202409097RSE
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Evaluation of Bifidobacterium Animalis Subsp. Lactis TCI604 Probiotic on Intestinal Function Improvement
- ClinicalTrials.gov ID
- NCT07135362
- Acronym / sponsor ID
- 202409097RSE
- Conditions
- Constipation, Intestinal Functional Disorder
- Keywords
- Bifidobacterium animalis subsp. lactis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTaking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks |
| TCI604 probiotics | Experimental | Dietary Supplement: TCI604 probioticsTaking 1 sachet of the testing sample with water every morning before breakfast for 4 consecutive weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCI604 probioticsAlso: Bifidobacterium animalis subsp. lactis TCI604TCI604 probiotics sachet | Dietary supplement | TCI604 probiotics |
| PlaceboPlacebo sachet | Dietary supplement | Placebo |
Primary outcome
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).
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaw-Shiun Tsai, Doctor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI604 probiotics in people with Constipation and Intestinal Functional Disorder, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ping Lin, Ms. (+886-87977811, candice.lin@tci-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of stool form (time frame: Week 0 (Baseline), Week 2, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.