Research on the Role of Probiotics in Human Intestinal Health

ConditionIntestinal Microbiota

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorWecare Probiotics Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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).

Treatment groups

45 Participants

are divided into 2 treatment groups

Group A: Probiotic groupActive comparator 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wecare Probiotics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: