Research on the Role of Probiotics in Human Intestinal Health

NCT06886711 | Not Yet Recruiting

• 1 other identifier: WK20250306
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Probiotics; Intestinal Barrier Function

Outcome Measures

Primary Outcomes (1)

• Change in Fecal Microbiota Composition Before and After Intervention

  Fecal microbiota composition will be analyzed using 16S rRNA gene sequencing to assess taxonomic and relative abundance changes.

  Baseline (Week 0) and post-intervention (Week 8)

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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).

Probiotic group

Placebo 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).

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to attend 3 follow-up visits during the intervention period
• Agree to provide blood, urine, and stool samples twice during the intervention period
• Good eyesight, able to read and write, and capable of wearing glasses if needed
• Good hearing and able to fully comprehend all instructions during the intervention

You may not qualify if:

• Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
• 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)
• History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
• Currently taking medication for depression or low mood
• Presence of internal organ failure (e.g., heart, liver, or kidney failure)
• History of radiation therapy or chemotherapy treatments
• Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
• History of hepatitis (B or C), HIV, or syphilis

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Technology

Zhengzhou, Henan, 210095, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Xu Fei Doctor

CONTACT

13671979116; xu.fei@haut.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 20, 2025
• Study Start: March 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CN (1)