Diet and Fecal Incontinence in Senior Women
Diet Modification Program for Senior Women With Fecal Incontinence
調査の概要
詳細な説明
Study Procedure: Visit Schedule
Visit 1(Baseline visit): Following consent, the study coordinator will obtain participant's demographic data including age, race/ethnicity, body mass index. Data on medical comorbidities, surgical history and medications known to be associated with FI will be collected. The participant's severity of FI will be measured using the St. Mark's Vaizey scale (Vaizey). The impact of FI on quality of life will be measured using the Fecal Incontinence Quality of Life scale (FIQL). The presence, type, and severity of other pelvic floor symptoms known to be associated with FI will be assessed using the Pelvic floor Distress Inventory- Short Form. Participants will be given a Food and Bowel Symptom diary and a stool collection kit at the conclusion of the visit.
Visit 2(Intervention visit): Stool sample will be collected by the study coordinator. Investigators will administer the DMP. Participants will be given the booklet outlining the DMP and investigators will review the participant's Food and Symptom diary and provide targeted recommendations. The participant will be given a second Food and Symptom diary and stool collection kit to return 6 weeks after the intervention start date.
Calls: Trained Nutritionists will call the participant between weeks 2 and 4 for three unannounced 24h diet recall. The 24-hour dietary recalls will be collected using Nutrition Data System for Research, a computer-based software application that facilitates the collection of recalls in a standardized fashion.
Visit 3 (Follow up visit): Post intervention stool samples and Food and Symptom diary will be collected. Questionnaires including the Vaizey, FIQL, Pelvic Floow Disability Index (PFDI), and Patient Global Index of Improvement (PGI-I) will be administered by the study coordinator. Participants will receive compensation for participating in the study.
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
-
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Hospital of the University of Pennsylvania
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-
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:
- Age ≥ 65 years,
- FI defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment,
- adequate mobility for independent toileting,
- ability for independent completion of food symptom diary,
- has some control of her diet and is able to make adjustments
- able to read and communicate in English,
- willing to give informed consent
Exclusion Criteria:
- Currently receiving another treatment for FI
- significant cognitive impairment at baseline
- residence in a care facility that provides meals (participants who are not able to adjust their diet will be excluded because the intervention focuses on the participant, not their care facility)
- current bloody diarrhea,
- current or past diagnosis of colorectal
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：Diet Modification Pilot Program
Investigator will administer DMP which will include a review of the booklets and any targeted recommendations based on the participant's food and symptom diary.
The participant will follow the DMP for 6 weeks and report for a follow-up visit.
|
Investigator will administer DMP which will include a review of the booklets and any targeted recommendations based on the participant's food and symptom diary.
The participant will follow the DMP for 6 weeks and report for a follow-up visit.
|
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 |
|---|---|---|
|
Change in FI Symptoms (Vaizey)
時間枠：6 weeks
|
Changes in the participant's symptom severity will be assessed from baseline to study conclusion.
|
6 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in stool metabolites
時間枠：6 weeks
|
Change from baseline in levels of stool deoxycholic acid(DCA, µmol/g feces)
|
6 weeks
|
協力者と研究者
捜査官
- 主任研究者：Uduak U Andy, MD、University of Pennsylvania
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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。