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
{"title":"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","authors":"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","doi":"10.1016/j.cct.2025.107834","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div><div><span><span><strong>Clinicaltrials.gov</strong></span><svg><path></path></svg></span> <strong>ID:</strong> <span><span>NCT05123612</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107834"},"PeriodicalIF":1.9000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of fermented and fiber-rich foods on maternal & offspring microbiome study (FeFiFo-MOMS) — Study design and methods\",\"authors\":\"Catherine P. 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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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div><div><span><span><strong>Clinicaltrials.gov</strong></span><svg><path></path></svg></span> <strong>ID:</strong> <span><span>NCT05123612</span><svg><path></path></svg></span></div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"150 \",\"pages\":\"Article 107834\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S155171442500028X\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S155171442500028X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/1 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.
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.