Evaluating and Treating Potential Research Participants With Digestive Disorders
Evaluation and Treatment Protocol for Potential Research Participants With Digestive Disorders
Background:
- Some research studies focus on digestive disorders, such as nutritional, gastrointestinal, and liver disorders. Researchers want to examine and treat people with digestive disorders in order to learn more about these disorders. They also want to study how digestive disorders run in some families. To do so, they will provide standard care to people with digestive disorders. They will also look at relatives of people with digestive disorders, such as parents, children, and siblings.
Objectives:
- To examine and treat people with digestive disorders.
- To evaluate people with digestive disorders for research studies.
Eligibility:
- Individuals of any age who have digestive disorders.
- Individuals at least 2 years of age who are first-degree relatives of the people with digestive disorders.
Design:
- Participants will have at least one outpatient visit to the National Institutes of Health. The visit will last about 2 hours.
- All participants will be screened with a physical exam and medical history. They will also provide different samples for study. Samples may include blood, urine, and stool samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may be collected from adult participants.
- Participants with digestive disorders may be able to receive treatment through this study.
調査の概要
詳細な説明
The National Institute of Nursing Research (NINR) is conducting a protocol to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed digestive conditions. Investigators of this protocol provide GI consultation at the NIH Clinical Center for a range of GI conditions.
Objectives: The primary objective of this protocol is to allow digestive care specialists in NINR and other institutions to provide standard of care. Evaluating and treating participants will allow digestive care specialists to maintain their expertise and gain additional knowledge of the course of various digestive disorders. Additionally this protocol will allow for hypothesis generation and provide a resource of patients for enrollment into new research protocols throughout the NINR branches. The information obtained will allow for the evaluation of standard treatments of the studied digestive diseases. This understanding may lead to ideas for future protocols. The protocol will also allow for trainees to receive training in the management of digestive disorders.
Study Population: The number of participants for this evaluation and treatment protocol will be set to 500 patients with digestive disorders and their unaffected first-degree relatives.
Design: This is a natural history evaluation and treatment protocol of the progression and physiology of multiple digestive disorders. Blood or other biologic samples (including but not limited to stool, urine, saliva, hair, cheek swab, or tissue) will be obtained through non-invasive means or incidentally to clinical care for future laboratory studies. In addition, genetic samples may be collected from unaffected first-degree relatives and may be used to identify and verify causative mutations.
Outcome Measures: The outcome measures for this protocol are the clinical assessments of enrolled participants, including their response to standard treatments. Also, causative mutations may help establish pathogenic mechanisms and genotype-phenotype correlations.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
- INCLUSION CRITERIA:
This protocol will include participants from birth and has no upper age limit.
Participants will be eligible if they:
- Have either a digestive disorder, OR
- Are an unaffected first-degree relative ( >2 years old) of a participant with a digestive disorder.
EXCLUSION CRITERIA:<TAB>
Participants will not be eligible if they:
- Are unwilling to give informed consent or, if a minor, do not have a parent or guardian able to provide consent, cannot assign a Durable Power of Attorney (DPA) or if a minor, do not have a parent or guardian able to provide consent.
- Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.
- NINR employees, subordinates/relatives/ or co-workers
- Any NIH employess who is a subordinate/relative/or co-worker of a study investigator
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：1
Standard of Care.
Participants will be evaluated and treated for their particular digestive disorder or presenting symptoms.
|
Any evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder.
|
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 |
|---|---|---|
|
Evaluation and treatment of GI disorders
時間枠：Outcomes will be assessed periodically according to disorder and severity.
|
This protocol allows NINR investigators to provide treatment for GI disorders and maintain knowledge and expertise of GI disorders.
|
Outcomes will be assessed periodically according to disorder and severity.
|
協力者と研究者
捜査官
- 主任研究者：Wendy A Henderson, C.R.N.P.、National Institute of Nursing Research (NINR)
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
Standard of Careの臨床試験
-
VA Office of Research and Developmentまだ募集していません
-
RWTH Aachen UniversityBiotest募集
-
Compedica IncProfessional Education and Research Institute完了
-
DeRoyal Industries, Inc.Lincoln Memorial University完了皮膚感作 | 機械的、熱的、および放射線刺激に対する皮膚反応アメリカ
-
University of PennsylvaniaMarch of Dimes積極的、募集していない
-
University of PittsburghShadyside Hospital Foundation完了
-
Saint-Joseph University完了