发酵和富含纤维的食物对母代和子代微生物组研究(feffo - moms)的影响-研究设计和方法

IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2025-03-01 Epub Date: 2025-02-01 DOI:10.1016/j.cct.2025.107834
Catherine P. Ward , Dalia Perelman , Lindsay R. Durand , Jennifer L. Robinson , Kristen M. Cunanan , Sailendharan Sudakaran , Roujheen Sabetan , Maggie J. Madrigal-Moeller , Christopher Dant , Erica D. Sonnenburg , Justin L. Sonnenburg , Christopher D. Gardner
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引用次数: 0

摘要

背景:最近的研究强调了肠道微生物群在人类健康中的关键作用,特别是在体内平衡改变的状态下,包括怀孕。此外,尚不清楚怀孕期间饮食变化如何影响母亲和孩子的微生物群发育。方法:本文描述了我们的随机对照试验,发酵和富含纤维的食物对母代和子代微生物组的研究(feffo - moms)的研究设计和方法。我们招募了135名怀孕早期的妇女,将她们随机分为四个饮食组:增加纤维,增加发酵食品,两者都增加,没有饮食干预作为对照组。在怀孕期间收集样本,持续到出生后18 个月,用于临床、微生物组和免疫标志物分析。结果:我们的试验设计旨在研究饮食干预(特别是增加高纤维和发酵食品的摄入)对母亲肠道微生物群多样性及其随后传播给婴儿的影响。结论:FeFiFo-MOMS试验旨在通过微生物群介导的机制,为可能影响母婴健康的可调节饮食因素提供有价值的见解,并研究饮食对孕妇和婴儿健康和疾病的更广泛影响。临床试验:govID: NCT05123612。
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Effects of fermented and fiber-rich foods on maternal & offspring microbiome study (FeFiFo-MOMS) — Study design and methods

Background

Recent research underscores the crucial role of the gut microbiota in human health, particularly during states of altered homeostasis, including pregnancy. Additionally, it is not well understood how dietary changes during pregnancy affect the development of microbiomes of both mother and child.

Methods

Here, we describe the study design and methods for our randomized controlled trial, the fermented and fiber-rich foods on maternal and offspring microbiome study (FeFiFo-MOMS). We enrolled 135 women during early pregnancy, randomizing them to one of four diet arms: increased fiber, increased fermented foods, increase in both, and no dietary intervention as a comparator arm. Samples were collected across pregnancy continuing to 18 months post-birth for clinical, microbiome, and immune marker analysis.

Results

Our trial design intended to investigate the effects of dietary interventions—specifically, increased intake of high-fiber and fermented foods—on maternal gut microbiota diversity and its subsequent transmission to infants.

Conclusion

The FeFiFo-MOMS trial was designed to provide valuable insights into the modifiable dietary factors that could influence maternal and infant health through microbiota-mediated mechanisms and examine the broader implications of diet on pregnant mothers' and infants' health and disease.
Clinicaltrials.gov ID: NCT05123612
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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