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Study of the effect of single supplementation of Lactiplantibacillus plantarum on the intestinal flora of normal humans

Study of the effect of single supplementation of Lactiplantibacillus plantarum on the intestinal flora of normal humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073555
Enrollment
Unknown
Registered
2023-07-14
Start date
2023-07-16
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

None

Interventions

CCFM8610 intervention group:During the trial, baseline is to be collected and probiotic CCFM8610 (10^9 CFU) is to be ingested for one day only, with one stool per day on the day of the intervention an
Placebo group:During the trial, baseline needs to be collected, placebo (maltodextrin) is ingested for one day only and stools are taken once a day on the day of the intervention and 7 days after the

Sponsors

School of Food Science and Technology, Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Healthy men and women aged 18 to 70 years, with a male to female ratio of 1:1; (2) Not currently following any dietary programme or dietitian consultation; (3) BMI: 18.5 to 24.9 kg/m2; (4) Compliance with relevant regulations during the clinical trial, good adherence and ability to deliver samples on time; (5) The volunteer or guardian has signed the informed consent form; (6) Volunteers commit to cooperate with the study throughout the experimental period.

Exclusion criteria

Exclusion criteria: (1) Suffering from gastrointestinal, neurological, cardiovascular, endocrine, renal or other chronic diseases that may affect the dynamics of the bowel; (2) Having undergone major abdominal surgery, especially of the gastrointestinal tract; (3) Use of medication related to gastrointestinal conditions such as anti-spasmodics, laxatives, anti-diarrhoeal drugs and other drugs that have an effect on intestinal motility within two weeks; (4) Women during pregnancy or lactation; (5) Allergy or lactose intolerance to the ingredients of the experimental probiotic product; (6) Consumption of yoghurt, probiotics, prebiotics, synbiotics, dietary supplements, or herbal medicines within 1 month or for a prolonged period of time, herbal remedies, or taking high doses of vitamins or minerals; (7) Use of antibiotics within 1 month or for a prolonged period, glucocorticoids, immunosuppressive drugs within 3 months or for a prolonged period (8) Significant change in dietary habits within 1 month, such as starting a fibre-rich diet (>18 g/day) (9) Hospital diagnosis of chronic illness, immune system disorders, mental illness, infectious diseases or major diseases; (10) Alcohol or substance abuse; (11) Currently or recently (within 1 month) undergoing another clinical study; (12) Refusal to sign an informed consent form or poor estimated compliance and poor likelihood of follow-up.

Design outcomes

Primary

MeasureTime frame
gut microbiota;

Secondary

MeasureTime frame
metabolome;

Countries

China

Contacts

Public ContactZhai Qixiao

School of Food Science and Technology, Jiangnan University

zhaiqixiao@sina.com+86 159 6176 0920

Outcome results

None listed

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