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

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWecare Probiotics Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Willing to self-administer probiotic or placebo once a day during the intervention period

Good eyesight, can read and write, can wear glasses

Have good hearing and be able to hear and understand all instructions during the intervention

Disqualifiers

Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)

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)

Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder

Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)

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 (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).

  • Placebo

    Dietary supplement

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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Probiotic GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the concentration of antimicrobial peptides (LL-37 and calprotectin) in feces before and after intervention

Detected by Enzyme-Linked Immunosorbent Assay (ELISA).

Time frame
Week 0 and Week 8

Secondary outcomes

Other outcomes

Sponsors and contacts

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

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