Study on the Enhancement of Intestinal and Immune Functions Through Probiotic Intervention

Wecare Probiotics

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06863415

WK20250305

Details and patient eligibility

About

Evaluate the effectiveness and safety of Bifidobacterium longum subsp. infantis BI45 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
2. Willing to self-administer probiotic or placebo once a day during the intervention period
3. Good eyesight, can read and write, can wear glasses
4. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion criteria

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
5. Have received radiation or chemotherapy in the past
6. Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
7. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

Probiotic Group

Experimental group

Description:

Intervention with Bifidobacterium longum subsp. infantis BI45 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.

Treatment:

Dietary Supplement: Probiotic

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo