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Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia (IMAGINE)

14 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Recrutement
        • Massachusetts General Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Functional Dyspepsia, Healthy Control, Anorexia Nervosa
Autre: Functional magnetic resonance imaging (fMRI)
Pineapple pudding snack, with pre- and post-snack fMRI

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Visual interoception task
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Collaborateurs

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Les enquêteurs

  • Chercheur principal: Helen Burton-Murray, PhD, Massachusetts General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 mars 2026

Achèvement primaire (Estimé)

1 mars 2030

Achèvement de l'étude (Estimé)

1 mars 2031

Dates d'inscription aux études

Première soumission

29 juin 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025P001856
  • R01DK145599 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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