Research on the Role of Probiotics in Human Intestinal Health

NCT ID: NCT06886711

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-12-30

Brief Summary

Evaluate the efectiveness and safety of Bifidobacterium bifidum BBi32 as a food supplement compared to a placebo in improving intestinal andimmune functions in healthy adults.

Conditions

Intestinal Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Intervention with Bifidobacterium bifidum BBi32 (30 billion CFUday, 3g) was administered daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement: Probiotics. The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).

Placebo group

Every day to give 3 g maltodextrin intervention for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement: Placebo. The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).

Interventions

Probiotic

Dietary supplement: Probiotics. The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Dietary supplement: Placebo. The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Willing to attend 3 follow-up visits during the intervention period

2. Agree to provide blood, urine, and stool samples twice during the intervention period

3. Good eyesight, able to read and write, and capable of wearing glasses if needed

4. Good hearing and able to fully comprehend all instructions during the intervention

Exclusion Criteria

1. Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)

2. History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)

3. History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder

4. Currently taking medication for depression or low mood

5. Presence of internal organ failure (e.g., heart, liver, or kidney failure)

6. History of radiation therapy or chemotherapy treatments

7. Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period

8. History of hepatitis (B or C), HIV, or syphilis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan University of Technology

Zhengzhou, Henan, China

Countries

China

Central Contacts

Xu Fei Doctor

Role: CONTACT

xu.fei@haut.edu.cn

13671979116 ext. 86

Facility Contacts

Xu fei Doctor

Role: primary

xu.fei@haut.edu.cn

13671979116 ext. 86

Other Identifiers

WK20250306

Identifier Type: -

Identifier Source: org_study_id