Stanford University Microbiome Bank (SUMB)
調査の概要
詳細な説明
Eligible participants will undergo comprehensive baseline screening including physical examination, infectious disease testing, and health history assessment. Those who qualify will enter an active donation period of up to 12 months, during which they will provide stool samples at a frequency ranging from once per month to once per week, depending on their availability.
In addition to stool collection, participants will provide biospecimens including blood draws (for infectious disease and metabolic monitoring), saliva samples, and small intestinal fluid samples collected using an ingestible capsule device (CapScan). The CapScan capsule is swallowed by the participant, collects intestinal fluid as it passes through the small intestine, and is retrieved from stool and returned to the research team for analysis.
This biobank will serve as infrastructure for ongoing microbiome research, providing rigorously screened and comprehensively characterized biospecimens to advance understanding of the gut microbiome's role in health and disease, and to support development of safe and effective microbiota-based therapies.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Roujheen Sabetan, MPH
- 電話番号:650-498-8188
- メール:rsabetan@stanford.edu
研究場所
-
-
California
-
Palo Alto、California、アメリカ、94305
- Stanford University
-
コンタクト:
- Roujheen Sabetan, MPH
- 電話番号:650-498-8188
- メール:rsabetan@stanford.edu
-
主任研究者:
- Sean Spencer, MD, PHD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any person aged 18-80 years of age, inclusive at the time of signing the consent
- In good general health as evidenced by medical history
- Ability to travel to donation facility on a weekly basis
- Residence within 5 miles of Stanford Campus
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- Capable of providing signed informed consent.
Exclusion Criteria:
- Inflammatory bowel disease
- Enteric infections
- Previous infection with Clostridium difficile
- History of gastrointestinal surgery: Participants with gastrointestinal surgeries below the pylorus will be excluded from this protocol, including participants with a history of colectomy, segmental colonic resection, and small bowel resections.
- Documented severe gastroparesis
- Active intestinal obstruction
- Dysphagia (oropharyngeal, esophageal, functional or neuromuscular)
- History or current malignancy diagnosis
- History of recurrent aspiration episodes
- Any conditions associated with a high risk of bleeding, including but not limited to coagulopathy/bleeding disorder, severe liver disease, active or recent GI bleeding, or recent abdominal or other GI surgery
- Active diagnosis of major depressive disorder
- Active diagnosis of major anxiety disorder
- Severe immunodeficiency, inherited or acquired (e.g., Human immunodeficiency virus, active chemotherapy or immunosuppressive medications [including steroids, biologic therapy, or bone marrow suppressive agents], or radiation therapy)
- BMI of less than 18 or BMI greater than 30
- Record of eating disorders
- Active use of GLP-1 inhibitors
- Diagnosis of Human immunodeficiency virus infection; Hepatitis A, B, C & E; Epstein Bar Virus; parasitic infections; Syphilis
- Pregnancy & lactation
- Active drug, or alcohol use disorder
- Tobacco, marijuana and e-cigarette use
- Any other significant medical condition that could confound or interfere with evaluation of safety or tolerability or prevent compliance with the study protocol at the discretion of the Investigator
Prior/concomitant therapy
- Active antibiotic use
- Active treatment with high levels of immunosuppressive therapies (active chemotherapy or immunosuppressive medications [including steroids, biologic therapy, or bone marrow suppressive agent], or radiation therapy)
- Simultaneous participation in another interventional clinical trial
Other exclusion criteria
-Inability to comply with research requirements
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Healthy Donors
This group consists of healthy stool donors.
|
This is an observational study with no interventions.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Donor Eligibility Rate
時間枠:During screening period
|
Proportion of screened individuals who meet eligibility criteria for stool donation
|
During screening period
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Microbiome Diversity of Donors
時間枠:Baseline and every 60 days through study completion, up to 12 months
|
Alpha diversity (e.g., Shannon index) of stool samples from eligible donors
|
Baseline and every 60 days through study completion, up to 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Sean Spencer, MD, PhD、Stanford University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB 85544
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。