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Health and safety of seven probiotics in Chinese population

Health and safety of seven probiotics in Chinese population

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085790
Enrollment
Unknown
Registered
2024-06-18
Start date
2023-07-24
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Experimental group 1:Lactobacillus plantarum HFY15*14 days
Experimental group 2:Lactobacillus plantarum PL15A*14 days
Experimental group 3:Lactobacillus plantarum H6*14 days
Experimental group 4:Lactobacillus acidophilus LA-10A*14 days
Experimental group 5:Lactobacillus reuteri LR09*14 days
Experimental group 6:Bifidobacterium longum BL300*14 days
Experimental group 7:Bifidobacterium breve BB05*14 days

Sponsors

The First People's Hospital of Kunshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Natural persons aged 18-45 years old, controlling sex at about 1:1; 2. Have not taken antibiotics within one month, and have not taken products containing probiotics within half a month; 3. Those who have not suffered from gastrointestinal diseases within one month; 4. Local subjects, no business trips; 5. Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, allergic constitution; 2. Patients with serious diseases and endocrine diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and psychosis; 3. Those who have taken antibiotics within one month or foods related to probiotics within 14 days, which affects the judgment of the results; 4. Subjects who other investigators deem unsuitable to participate in this trial, as well as subjects participating in other clinical trials. 4. Other researchers think that they are not suitable to participate in this trial, as well as subjects participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The colonization time of the strain in the subject's intestine;Microbiota analysis(QPCR and Metagenome sequence);

Secondary

MeasureTime frame
Bristol Stool Form Scale;Gastrointestinal Symptom Rating Scale, GSRS;

Countries

China

Contacts

Public ContactXu Yihui

The First People's Hospital of Kunshan

932551223@qq.com+86 512 5751 9231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026