The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTCI Co., Ltd.
About this trial
The objective of this study is to evaluate whether the TCI604 probiotics has the potential to enhance human gut function and alleviate constipation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
TCI604 probiotics
Dietary supplementTCI604 probiotics sachet
Placebo
Dietary supplementPlacebo sachet
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: TCI604 probioticsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Week 0 (Baseline), Week 2, Week 42
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.
Time frame
Week 0 (Baseline), Week 2, Week 4Secondary outcomes
1
The change of intestinal microbiota
Collect participant's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS).
Time frame
Week 0 (Baseline), Week 42
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.
Time frame
Week 0 (Baseline), Week 43
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.
Time frame
Week 0 (Baseline), Week 44
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.
Time frame
Week 0 (Baseline), Week 4Other outcomes
1
The change of Body weight
Body weight will be assessed by Body Composition Analyzer. Unit: kg
Time frame
Week 0 (Baseline), Week 42
The change of Body Mass Index
Body Mass Index (BMI) level will be assessed by Body Composition Analyzer. Unit: kg/cm\^2
Time frame
Week 0 (Baseline), Week 43
The change of Percent Body Fat
Percent Body Fat will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: Percent
Time frame
Week 0 (Baseline), Week 44
The change of Visceral Fat Level
Visceral Fat Level will be assessed by Bioelectrical Impedance Analysis (BIA) method. Unit: arbitrary unit
Time frame
Week 0 (Baseline), Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov