Feigelson Heather Spencer, Bischoff Kimberly, Ardini Mary-Anne E, Ravel Jacques, Gail Mitchell H, Flores Roberto, Goedert James J
Institute for Health Research, Legacy Highlands, Suite 300, Kaiser Permanente Colorado, P,O, Box 378066, Denver, CO, USA.
BMC Res Notes. 2014 Apr 1;7:204. doi: 10.1186/1756-0500-7-204.
The field of microbiome research is growing rapidly. We developed a method for self-collection of fecal specimens that can be used in population-based studies of the gut microbiome. We conducted a pilot study to test the feasibility of our methods among a random sample of healthy, postmenopausal women who are members of Kaiser Permanente Colorado (KPCO). We aimed to collect questionnaire data, fecal and urine specimens from 60 women, aged 55-69, who recently had a normal screening mammogram. We designed the study such that all questionnaire data and specimens could be collected at home.
We mailed an invitation packet, consent form and opt-out postcard to 300 women, then recruited by telephone women who did not opt-out. Verbally consented women were mailed an enrollment package including a risk factor questionnaire, link to an online diet questionnaire, specimen collection kit, and instructions for collecting stool and urine. Specimens were shipped overnight to the biorepository. Of the 300 women mailed an invitation packet, 58 (19%) returned the opt-out postcard. Up to 3 attempts were made to telephone the remaining women, of whom 130 (43%) could not be contacted, 23 (8%) refused, and 12 (4%) were ineligible. Enrollment packages were mailed to 77 women, of whom 59 returned the risk factor questionnaire and specimens. We found no statistically significant differences between enrolled women and those who refused participation or could not be contacted.
We demonstrated that a representative sample of women can be successfully recruited for a gut microbiome study; however, significant personal contact and carefully timed follow-up from the study personnel are required. The methods employed by our study could successfully be applied to analytic studies of a wide range of clinical conditions that have been postulated to be influenced by the gut microbial population.
微生物组研究领域正在迅速发展。我们开发了一种粪便标本自我采集方法，可用于基于人群的肠道微生物组研究。我们进行了一项试点研究，以测试我们的方法在科罗拉多州凯撒医疗机构（KPCO）的健康绝经后女性随机样本中的可行性。我们的目标是从60名年龄在55 - 69岁、最近乳房X线筛查正常的女性中收集问卷数据、粪便和尿液标本。我们设计该研究以便所有问卷数据和标本都能在家中收集。
我们向300名女性邮寄了邀请函、同意书和退出明信片，然后通过电话招募未退出的女性。口头同意的女性会收到一份注册包，其中包括风险因素问卷、在线饮食问卷链接、标本采集试剂盒以及粪便和尿液采集说明。标本通过隔夜快递送到生物样本库。在邮寄邀请函的300名女性中，58名（19%）返回了退出明信片。我们对其余女性进行了多达3次电话联系，其中130名（43%）无法联系上，23名（8%）拒绝参与，12名（4%）不符合条件。注册包被邮寄给77名女性，其中59名返回了风险因素问卷和标本。我们发现已注册女性与拒绝参与或无法联系上的女性之间没有统计学上的显著差异。
我们证明了可以成功招募到具有代表性的女性样本进行肠道微生物组研究；然而，研究人员需要进行大量的个人联系并进行精心安排的随访。我们研究中采用的方法可以成功应用于对一系列假定受肠道微生物群影响的临床病症的分析研究。
