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Randomized controlled study of the effects of Bifidobacterium longum spp. Infantis YLGB-1496 on the health of infants and toddlers aged 0-36 months

Randomized controlled study of the effects of Bifidobacterium longum spp. Infantis YLGB-1496 on the health of infants and toddlers aged 0-36 months

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059872
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Dysbacteriosis

Interventions

Intervention group:Take 1 bag (2g) of bacterial powder containing Bifidobacterium longum spp. Infantis YLGB-1496 every day
Control group:Take 1 bag of placebo maltodextrin (2g) in the same package as the bacterial powder every day
Exclusive breastfeeding group:Only observation and follow-up, no intervention

Sponsors

Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Healthy infants aged 0-36 months delivered at full term meet the standards for healthy infants of their age group, and their parents can understand the requirements of the agreement and complete the baby diary as required; 2. Healthy, singleton or twin, gestational age >= 37 weeks (who), birth weight >= 2500 g, current weight is between P20 and p80 according to the percentage map of the weight of children aged 0-18; 3. The intervention group and the control group were infants fed with mixed feeding or artificial feeding; 4. Infants in the pure breast milk group did not add infant formula and supplementary food; 5. No gastrointestinal diseases within 1 month; 6. Do not use antibiotics within 1 month; 7. Parents agree to take the recommended probiotics; 8. The infant formula does not contain probiotics, and can only contain galactooligosaccharide (GOS) < 2G/100g as prebiotics without fructooligosaccharides.

Exclusion criteria

Exclusion criteria: 1. Congenital disease or deformity; Severe prenatal and post natal diseases; Mothers with metabolic and / or chronic diseases; Probiotic allergy constitution; Infants with serious diseases, such as cardiovascular diseases, cerebrovascular, endocrine, liver, kidney and hematopoietic system or mental diseases; 2. Ingestion of other drugs that may affect the effect during the study, resulting in failure to judge the efficacy of probiotics and/or affect the judgment of results; 3. Current or previous diseases or conditions or interventions that may interfere with the study (affect tolerance and / or growth and development), such as gastrointestinal malformations, chronic diarrhea, malabsorption syndrome, malnutrition, congenital immunodeficiency or major surgery; 4. Oral antibiotics or other drugs or nutritional supplements containing probiotics, and prebiotics (except infant formula) within 2 weeks before intervention; 5. Food for special medical purposes with non-standard formula powder, used for lactose intolerance and galactosemia; 6. Infants with possible food allergy, such as milk allergy, soy protein allergy, fish protein allergy and egg protein allergy; 7. 4 weeks before intervention, participated in or had participated in other clinical studies; 8. The legal guardian of the baby has mental or mental illness and does not have the language ability to sign the informed consent form; 9. The investigator can judge the reason why the infant's parents cannot meet the requirements of the study record (such as being unable to contact the investigator in an emergency, or suffering from drug and alcohol addiction).

Design outcomes

Secondary

MeasureTime frame
Weight;Height;

Primary

MeasureTime frame
sIgA;Intestinal flora;TNF-a;

Countries

China

Contacts

Public ContactYumei Zhang

Department of Nutrition and Food Hygiene, School of Public Health, Peking University

zhangyumei@bjmu.edu.cn+86 13426134251

Outcome results

None listed

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