The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement

TCI

Status: Enrolling

Conditions: Intestinal Functional Disorder; Constipation

Treatments: Dietary Supplement: TCI604 probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07135362

202409097RSE

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

TCI604 probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: TCI604 probiotics