The Effect of Probiotics on the Improvement of Intestinal and Immune Function

Wecare Probiotics

Status: Completed

Conditions: Intestinal and Immune Function Improved

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Probiotic group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06873438

WK20250304

Details and patient eligibility

About

Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.

Enrollment: 52 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-45 years
2. Willing to undergo 3 follow-up visits during the intervention period
3. Willing to provide 2 blood, urine, and stool samples during the intervention period
4. Willing to self-administer one of the probiotics/placebo once daily during the intervention period
5. Good eyesight, able to read and write, and can wear glasses
6. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion criteria

1. Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease)
2. Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia)
3. Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood
5. Suffering from internal organ failure (heart, liver, or kidney failure, etc.)
6. Radiotherapy or chemotherapy in the past
7. Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial
8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Lactobacillus delbrueckii subsp. bulgaricus LB42 (30 billion CFU/day, 3g) was administered daily for 8 weeks. Store in a cool and dry place.

Treatment:

Dietary Supplement: Probiotic group

Placebo group

Placebo Comparator group

Description:

Every day to give 3g dextrin intervention for 8 weeks. Store in a cool and dry place.

Treatment:

Dietary Supplement: Placebo group