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Updated: Jun 29, 2025
Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Probiotics' effects on gut microbiota in jaundiced neonates: a randomized controlled trial protocol
Chen Jiayi1, Wei Jinying2, Yuan Yanhan1
1Pediatrics, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Insights
This study investigates how probiotics like Lactobacillus rhamnosus LGG affect the gut microbiota and side effects of phototherapy in jaundiced newborns. Probiotic interventions may help reduce therapy-related disturbances in infant gut health.
Area of Science:
- Neonatal Medicine
- Microbiology
- Gastroenterology
Background:
- Blue-light phototherapy for neonatal jaundice can alter gut microbiota composition.
- These alterations are linked to therapy-induced side effects.
- Targeting gut microbiota may mitigate these adverse effects.
Purpose of the Study:
- To evaluate the impact of specific probiotics (Lactobacillus rhamnosus LGG, Bifidobacterium animalis Bb-12, Bifidobacterium breve M-16V) on intestinal microbiota and metabolomics in jaundiced neonates.
- To assess the effect of these probiotics on phototherapy-related side effects.
Main Methods:
- A randomized, single-blind, controlled trial involving 100 jaundiced newborns.
- Intervention groups received daily oral probiotics (single strains or combination) alongside blue-light phototherapy.
- A control group received only blue-light phototherapy for 30 days.
Main Results:
- Primary outcomes include changes in gut microbiota and metabolomics profiles.
- Incidence of phototherapy side effects will be assessed throughout the 30-day follow-up period.
- Data collection includes assessments post-phototherapy and on days 10, 20, and 30.
Conclusions:
- Gut microbiota modulation via probiotics presents a potential strategy to manage phototherapy side effects in neonates.
- Further research is needed to confirm the efficacy and safety of these probiotic interventions.
Introduction:
Recent evidence suggests that blue-light phototherapy impacts gut microbiota composition in jaundiced newborns, leading to disturbances closely related to the therapy's side effects. As a result, gut microbiota may serve as a potential intervention target to mitigate these side effects. In this study, we aim to examine the effects of AB-GG (Lactobacillus rhamnosus LGG), Bb-12 (Bifidobacterium animalis Bb-12) and M-16V (Bifidobacterium breve M-16V) and their combination on the intestinal microbiota, metabolomics and phototherapy-related side effects in neonates with jaundice.
Methods And Analysis:
A total of 100 jaundiced newborns aged two weeks or younger will be included in this randomized, single-blind (the parents knew, but the neonatologists did not know), single-center controlled trial to receive either 109 colony-forming units of AB-GG, Bb-12, M-16V, a combination of the three probiotics with blue-light phototherapy, or blue-light phototherapy alone. The experimental group will be treated with oral probiotics once daily for 30 days, while the control group will receive only blue-light phototherapy. The follow-up duration will last 30 days. The primary outcomes include changes in gut microbiota, metabolomics, and the incidence of phototherapy side effects, assessed after each phototherapy session, as well as on days 10, 20, and 30.
Ethics And Dissemination:
The study protocol has been approved by the Ethics Committee of our institution. The findings of this trial will be submitted to a peer-reviewed pediatric journal. Its abstracts will be submitted to relevant national and international conferences.
Clinical Trial Registration:
http://www.chictr.org.cn/index.aspx, identifer (ChiCTR2000036013).
