Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
This study will focus on the commonly used non-nutritive sweetener (NNS) sucralose (2 sachets/day resulting in daily dose: sucralose 2.5mg/kg) and its role in changing the gut microbiota in humans with IBD, compared to healthy non-IBD individuals. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).
調査の概要
詳細な説明
Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).
Fecal & urine samples will be collected before/after each phase. Blood will also be collected.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Abigail Raffner, RD PhD
- 電話番号：216-327-6003
- メール：Abigail.Raffner@uhhospitals.org
研究連絡先のバックアップ
- 名前：Sargun Singh, M.B.B.S.
- 電話番号：216-333-6085
- メール：sargun.singh@uhhospitals.org
研究場所
-
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Ohio
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Chagrin Falls、Ohio、アメリカ、44122
- 募集
- UH Minoff Health Center
-
副調査官：
- Jeffry Katz, MD
-
コンタクト：
- Abigail Basson, RD PhD
- メール：Abigail.Basson@uhhospitals.org
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Cleveland、Ohio、アメリカ、44106
- 募集
- University Hospitals Cleveland Medical Center
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副調査官：
- Jeffry Katz, MD
-
コンタクト：
- Abigail Basson, RD PhD
- メール：Abigail.Basson@uhhospitals.org
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副調査官：
- Vu Nguyen, MD
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Westlake、Ohio、アメリカ、44145
- 募集
- UH Westlake Health Center
-
コンタクト：
- Abigail Basson, RD PhD
- メール：Abigail.Basson@uhhospitals.org
-
副調査官：
- Vu Nguyen, MD
-
-
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 range from: 18 to 70 years.
- Male or female.
- Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (<6 score).
- Capable of providing consent to participate.
- Able to complete daily surveys and take oral nutrition.
- Able to record meal intake.
- Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).
Exclusion Criteria:
- Short bowel syndrome.
- Hospitalized patients.
- Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
- Known drug abuse.
- Known parasitic disease of the digestive system.
- Symptomatic intestinal stricture/narrowing.
- Presence of an ostomy.
- Known active malignancy.
- Antibiotic use within last 14 days.
- Well-founded doubt about the patients cooperation.
- Existing pregnancy or lactation.
- History of <1 natural bowel movements per 3 consecutive days.
- Unable to access to technology that permits the daily completion of study related activities.
- Change in IBD medication within past 4 weeks.
- Body mass Index <18 kg/m or ≥35 kg/m.
- Documented C.difficile colitis within four weeks of screening.
- Bariatric surgery
- Phenylketonuria
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：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose |
Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg. This dose is below the acceptable daily intakes (ADI) of 5mg/kg. |
|
実験的：Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose |
Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg. This dose is below the acceptable daily intakes (ADI) of 5mg/kg. |
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 fecal microbiome measured by metagenome analysis
時間枠：Baseline, three weeks pre-intervention, and three weeks after intervention
|
Quantify the change in the fecal microbiome using metagenome analysis |
Baseline, three weeks pre-intervention, and three weeks after intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Fecal Myeloperoxidase activity (MPO)
時間枠：Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal MPO |
Baseline, three weeks pre-intervention, three weeks post-intervention
|
|
Change in Fecal Calprotectin
時間枠：Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal calprotectin |
Baseline, three weeks pre-intervention, three weeks post-intervention
|
|
Change in Crohn's Disease Activity Index (CDAI)
時間枠：Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
Quantify the change in Crohn's Disease Activity Index. The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity. It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation. Each component is multiplied by a specific weighting factor and summed to calculate a total score. Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity. A score of <150 indicates clinical remission, while a score of >450 indicates severe disease. A negative change from baseline indicates clinical improvement. |
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
|
Change in C-reactive protein (CRP)
時間枠：Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
Quantify change in CRP |
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
協力者と研究者
捜査官
- 主任研究者：Fabio Cominelli, MD PhD、University Hospitals Cleveland Medical Center
- 主任研究者：Abigail Raffner, RD PhD、Case Western Reserve University
研究記録日
主要日程の研究
研究開始 (実際)
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
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。