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

NCT06863415 | Not Yet Recruiting

• 1 other identifier: WK20250305
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

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).

  Week 0 and Week 8

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Intervention with Bifidobacterium longum subsp. infantis BI45 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.

Dietary Supplement: Placebo

Interventions

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).

Probiotic Group

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).

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Have received radiation or chemotherapy in the past
• Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
• Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Technology

Zhengzhou, Henan, 462000, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 15, 2025
• Primary Completion: October 10, 2025
• Study Completion: December 25, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

CN (1)