Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia (IMAGINE)
2026年8月14日 更新者：Helen Burton-Murray, PHD、Massachusetts General Hospital
This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa.
The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.
調査の概要
研究の種類
介入
入学 (推定)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Caroline Adams
- 電話番号：617-643-7884
- メール：imaginestudy@mgb.org
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- 募集
- Massachusetts General Hospital
-
コンタクト：
- IMAGINE Study Coordinator CRC
- 電話番号：617-643-7884
- メール：imaginestudy@mgb.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
はい
説明
Participant Inclusion Criteria--
Functional Dyspepsia Group:
- Males and females; ages 18-65 years
- Rome V functional dyspepsia post-prandial distress syndrome subtype
- Negative upper endoscopy or upper GI series to rule out structural/organic cause for FD
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Fluent in English
- Willing and able to provide informed consent
- Stable dose for 30 days prior to Visit 1 if on a neuropsychiatric medication (e.g., TCA, SNRI, SSRI mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)
- No current plans to initiate a new or change dosing on a neuropsychiatric medication within the study period
Anorexia Nervosa Group:
- Males and females; ages 18-65 years
- DSM-5 anorexia restricting-type by the Eating Disorder Module in the Diagnostic Interview for Mood, Anxiety, and OCD and related Neuropsychiatric Disorders (DIAMOND)
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Fluent in English
- Willing and able to provide informed consent
- Stable dose for 30 days prior to Visit 1 if on an SSRI
- No current plans to initiate a new neuromodulator
- No current plans to initiate a new SSRI or change dosing on an SSRI
Healthy Controls:
- Males and females; ages 18-65 years
- BMI greater than or equal to 18.5 kg/m2
- Fluent in English
- Willing and able to provide informed consent
Participant Exclusion Criteria--
Functional Dyspepsia Group:
Presence of other conditions that could explain the patient's symptoms by medical chart:
- Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT)
- Active H.pylori (by CLO test or stool antigen test)
- Active inflammatory bowel disease
- Eosinophilic gastroenteritis or eosinophilic esophagitis
- Acute renal failure
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Acute liver failure
- Any acute gastrointestinal process
- Any plausible structural or metabolic causes
- Heartburn as predominant symptom
- History of peptic ulcer
- Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- History of weight/shape-based eating disorder including anorexia nervosa by DIAMOND
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by modified DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
Anorexia Nervosa Group:
- Diagnosis of chronic gastrointestinal disorder
- Rome V functional dyspepsia
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
- Current use of neuropsychiatric medication other than an SSRI (e.g., TCA, SNRI, mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)
Healthy Controls:
- Diagnosis of chronic gastrointestinal or pain disorder
- Rome V functional dyspepsia
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Current use of a medication known to influence gastric sensorimotor functions (including neuromodulators and SSRIs)
- Active psychiatric disorder including a feeding/eating disorder by DIAMOND
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by DIAMOND modified suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：基礎科学
- 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：Functional Dyspepsia, Healthy Control, Anorexia Nervosa
|
Pineapple pudding snack, with pre- and post-snack fMRI
|
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 |
|---|---|---|
|
Visual interoception task
時間枠：Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan
|
The study team will be investigating brain activity and connectivity during an interoception task.
This will be measured via functional magnetic resonance imaging (fMRI) which is able to measure blood flow to regions of the brain.
|
Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan
|
|
Resting state connectivity
時間枠：Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.
|
Change in brain activity during rest pre and post prandially using functional magnetic resonance imaging (fMRI).
|
Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.
|
|
Gastric peristaltic velocity
時間枠：30 minutes (only in Visit 2, within approximately two weeks of Visit 1)
|
MRI-derived gastric motility outcome
|
30 minutes (only in Visit 2, within approximately two weeks of Visit 1)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Helen Burton-Murray, PhD、Massachusetts General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月16日
一次修了 (推定)
2030年3月1日
研究の完了 (推定)
2031年3月1日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月14日
最終確認日
2026年8月1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。