Growth development
Conditions
Interventions
Probiotic group:Bifidobacterium longum subsp. Infantis (Dipro-F) probiotic powder, once a day, one at a time, continuous intervention for 12 weeks.
Placebo group:Maltodextrin, once a day, one at a time, continuous intervention for 12 weeks.
Sponsors
Dalian Medical University; Dalian Women and Children's Medical Group
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: No-treatment control group 1.Aged 3 to 6 years old, no limitation on gender, with a gestational age of 37 to 42 weeks and birth weight of 2500 to 4000 g. 2.Healthy children diagnosed by clinicians within normal growth and development range. 3.Participants and their guardians must provide written informed consent for participation in this interventional study and exhibit the ability to understand and comply with the study protocol. Probiotic group and placebo group 1.Aged 3 to 6 years old, no limitation on gender, with a gestational age of 37 to 42 weeks and birth weight of 2500 to 4000 g. 2.Height between P3-P10 for same-age/sex children. (per the 2023 Guide for Dietary Management of Growth Retardation in Children and Adolescents and the Growth Standards for Children Aged <7 (WS/T 423—2022)) 3.Participants and their guardians must provide written informed consent for participation in this interventional study and exhibit the ability to understand and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Allergy to the trial product or its components. 2.Growth retardation due to genetic factors. 3.Severe diseases in thyroid, heart, liver, kidney, digestion, or hematopoietic systems, or severe malnutrition. 4.Be diagnosed with other diseases that may affect development. 5.Use of probiotics, antibiotics, immunostimulants, or immunosuppressants within 4 weeks before the trial. 6.(1) Chronic disease patients on medication; (2) Patients with severe organic lesions in thyroid, heart, brain, lung, kidney, or locomotor systems; (3) Patients with mental illness or relevant history; (4) Long-term corticosteroid users; (5) Users of growth hormone, gamma-aminobutyric acid, or L-methionine-B12. 7.Children meeting the growth hormone use criteria in the Chinese Pediatric Growth Hormone Deficiency Diagnosis and Treatment Guidelines. 8.Participants in other drug, dietary supplement, probiotic, or prebiotic clinical studies within the past 3 months. 9.Participants deemed unsuitable for the study by the researcher for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometric measurement assessments; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone density;Health questionnaires;Developmental Scales;Intestinal flora; | — |
Countries
China
Contacts
Public ContactHuajun Li; Lige Guo
Dalian Medical University; Dalian Women and Children's Medical Group
Outcome results
None listed