A randomized, double-blind, controlled cohort study on the effectiveness of an antenatal maternal supplementation with prebiotics or probiotics for reducing the risk of allergic diseases in children

Study on the effectiveness of an antenatal maternal supplementation with prebiotics or probiotics for reducing the risk of allergic diseases in children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048274

Enrollment

Unknown

Registered

2021-07-05

Start date

2021-11-01

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

Allergic diseases

Interventions

Experimental group 1:GOS-FOS prebiotics supplementation given

Experimental group 2:Inulin prebiotics supplementation given

Experimental group 3:Bifidobacterium brevis MV-16 and Lactobacillus rhamnosus HV001 given

Control group:Placebo (maltodextrin) given

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pregnant women (aged >=18 years) 32 weeks (+/-6 days) of gestation, visit the antenatal clinic; 2. With a history of atopic disease (defined as a health care professional diagnosis of asthma, allergic rhinitis, atopic eczema, or food allergy); 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects who are unwilling to stop taking other dietary supplements (including prebiotics or probiotics) during the supplementation period; 2. Have taken other probiotics, prebiotics or synbiotics products within the past 1 month; 3. Taking antibiotics, osmotic laxatives, anthraquinones and drugs that promote gastrointestinal motility within the past 1 month; 4. Any overt fetal or maternal pathology diagnosed before 32 weeks. Maternal pathology includes, but is not limited to, preeclampsia, hypertension, known autoimmune disease, infectious pathology, uterine malformations, cervical insufficiency or insufficiency requiring cervical cerclage, and gestational diabetes. Fetal pathology including (but not limited to) intrauterine growth restriction or small for gestational age, fetal malformations, oligohydramnios and polyhydramnios; 5. Suffering from severe acute or chronic diseases; 6. Suffering from gastrointestinal diseases; 7. Smoked during pregnancy; 8. Subjects allergic to cow's milk protein and/or lactose intolerant due to the lactose content of GOS-FOS; 9. Any other circumstances (eg, psychosocial problems) that the investigator considers inappropriate to participate in the study.

Design outcomes

Primary

Measure	Time frame
Incidence of atopic dermatitis;Incidence of cow's milk protein allergy;Life quality;	—

Countries

China

Contacts

Public ContactHong Li

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

hongli@scmc.com.cn+86 18930830869

Outcome results

None listed

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