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NCT Number: NCT06886711

Research on the Role of Probiotics in Human Intestinal Health

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.

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Key information

Conditions

Intestinal Microbiota

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

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).

Primary outcomes

  1. Change in Fecal Microbiota Composition Before and After Intervention

    Time frame: Baseline (Week 0) and post-intervention (Week 8)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Fei Doctor

CONTACT

[email protected]

13671979116 ext. 86

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

A Study on the Safety and Efectiveness of Bifidobacterium Bifidum BBi32 in Improving Lntestinal and Lmmune Functions

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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