The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics for Alleviating Functional Constipation in Adults

NCT06637397

Constipation

RECRUITING NA

The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

NCT04492605

Weight Loss

ACTIVE_NOT_RECRUITING NA

Efficacy of Probiotic Against Functional Constipation

NCT06122558

Constipation - Functional

RECRUITING PHASE2

Efficacy Assessment of Probiotics Product on Intestinal Health and Immune System Improvement

NCT04903600

Healthy

UNKNOWN NA

Probiotics Alleviate Functional Constipation in Adults

NCT06879587

Constipation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation Intestinal Functional Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo sachet

TCI604 probiotics

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

Group Type EXPERIMENTAL

TCI604 probiotics

Intervention Type DIETARY_SUPPLEMENT

TCI604 probiotics sachet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TCI604 probiotics

TCI604 probiotics sachet

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo sachet

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bifidobacterium animalis subsp. lactis TCI604

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes