Evidence map›Paper›PMID 39915586›Full record

Trial reportEuropean journal of clinical nutrition2025

Restoration of gut microbiota with a specific synbiotic-containing infant formula in healthy Chinese infants born by cesarean section.

Ying Wang, Harm Wopereis, Alexia Kakourou, Min Liu, Jieling Wu, Zailing Li, Lili Zhang, Meizhen Tan, June Su Yin Low, Mengjin Liu and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in European journal of clinical nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03520764 (A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03520764 nacompletednot on this map

A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants

TypeinterventionalSponsorDanone NutriciaRan2018 to 2020Enrolled284ConditionsHealthy InfantsArmsNew infant formula with synbiotics, Standard infant formula with prebiotics
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Ying Wang *Division of Pediatric Gastroenterology and Nutrition, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Harm Wopereis *Medical and Nutritional Science, Danone Research & Innovation, Utrecht, the Netherlands. harm.wopereis@danone.com.ORCID http://orcid.org/0000-0002-2103-1442
Alexia KakourouMedical and Nutritional Science, Danone Research & Innovation, Utrecht, the Netherlands.
Min LiuObstetrics Department, Shanghai Public Health Clinical Center, Shanghai, China.
Jieling WuDepartment of Children Health Care, Guangdong Women and Children Hospital, Guangzhou, China.
Zailing LiDepartment of Pediatrics, Peking University Third Hospital, Beijing, China.
Lili ZhangDepartment of Children Health Care, Wuxi Children's Hospital, Wuxi, China.
Meizhen TanDepartment of Children Health Care, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
June Su Yin LowD-Lab, Danone Research & Innovation, Singapore, Singapore.
Mengjin LiuDanone Open Science Research Centre, Danone Research & Innovation, Shanghai, China.
Guus RoeselersMedical and Nutritional Science, Danone Research & Innovation, Utrecht, the Netherlands.
Jan KnolMedical and Nutritional Science, Danone Research & Innovation, Utrecht, the Netherlands.ORCID http://orcid.org/0000-0002-2103-5961
Wei CaiDivision of Pediatric Gastroenterology and Nutrition, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. caiw1978@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBirth by cesarean section (C-section) is associated with a delayed colonization of bifidobacteria and Bacteroidota species with potential negative health consequences. Previously, an infant formula with a synbiotic mixture of short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS [9:1]) and Bifidobacterium breve M-16V was found to restore the timely colonization of bifidobacteria in C-section born infants. In this study, we investigated the effect of this synbiotic mixture on gut microbiota development in C-section and vaginally-born infants participating in a growth equivalence trial (NCT03520764).

methodsHealthy, fully formula-fed Chinese infants were randomized to receive a partially hydrolyzed whey-based protein formula with the synbiotic mixture (n = 112), or an intact protein formula with scGOS/lcFOS (prebiotic, n = 112). Breastfed infants served as reference group (n = 60). Gut microbiota profiling by 16S rRNA gene sequencing of stools collected at baseline, 17 weeks (end of intervention) and 12 months of age was complemented with analysis of stool pH, short-chain fatty acids, lactic acids, and secretory IgA concentrations.

resultsBoth the prebiotic and the synbiotic formula supported a dominant and diverse infant-type bifidobacterial community, but with increased abundance of Bifidobacterium breve in the synbiotic group. In C-section born infants (54.8% of randomized) the synbiotic but not the prebiotic, enhanced the bifidobacterial species diversity and showed restoration of Parabacteroides at 17 weeks, and Bacteroides spp. at 12 months closer to that of the vaginally-born infants.

conclusionThe synbiotic was confirmed to support the restoration of important gut colonizers in infants born by C-section with effects observed even beyond the intervention period.

Indexed as

Cesarean SectionGastrointestinal MicrobiomeInfant FormulaSynbioticsBifidobacteriumBifidobacterium breveChinaEast Asian PeopleFecesFemaleHumansInfantInfant, NewbornMaleOligosaccharidesOligosaccharides

Identifiers

PMID39915586
PMCPMC12151850

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.