Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT05417204
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominothoracic Muscular Tone in Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adaptive design: a sample size calculation based on the primary outcome will be performed after 30 patients complete the post-intervention evaluation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial fullness', 'timeFrame': '7 days', 'description': 'Change in postprandial fullness (measured on daily postprandial fullness scales graded from 0, i.e., not at all, to 10, i.e., extremely severe) during 7 consecutive days before and immediately after intervention.'}], 'secondaryOutcomes': [{'measure': 'Tolerance of a probe meal', 'timeFrame': '60 minutes', 'description': 'Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.'}, {'measure': 'Digestive well-being after a probe meal', 'timeFrame': '60 minutes', 'description': 'Change in digestive well-being after a probe meal (measured on a scale graded from -5, i.e., extremely negative, to +5, i.e., extremely positive) before and after intervention'}, {'measure': 'Postprandial fullness after a probe meal', 'timeFrame': '60 minutes', 'description': 'Change in postprandial fullness after a probe meal (measured on a scale graded from 0, i.e., not at all, to 10, i.e., extremely severe) before and after intervention'}, {'measure': 'Abdominal distension in response to a probe meal', 'timeFrame': '60 minutes', 'description': 'Changes in the girth response to a probe meal (measured by adaptive belts) before and after intervention.'}, {'measure': 'Diaphragmatic response to a probe meal', 'timeFrame': '60 minutes', 'description': 'Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional dyspepsia', 'Abdominal distension'], 'conditions': ['Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '33670508', 'type': 'RESULT', 'citation': 'Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.'}]}, 'descriptionModule': {'briefSummary': 'Background. Patients with functional dyspepsia report symptoms after eating without detectable cause. A recent proof-of-concept study demonstrated that in healthy subjects, the activity of the abdominal walls influences perception of digestive sensations, specifically, intentional abdominal distension (by a maneuver of diaphragmatic contraction) increased bloating sensation in response to a probe meal.\n\nAim. To determine the role of the abdominothoracic muscular activity on symptoms of functional dyspepsia.\n\nDesign. Parallel study in dyspeptic patients who have an abnormal somatic response to a probe meal (experimental group), and patients who do not (control group), comparing the effect of abdominophrenic biofeedback on dyspeptic symptoms. The probe meal will consist in stepwise ingestion of a comfort meal (hot ham and cheese sandwich plus orange juice) up to maximal satiation.\n\nIntervention. A standard biofeedback technique (3 sessions over a 4-week period) directed at controlling the muscular activity (postural tone) of the abdominal walls, will serve as active intervention in the experimental group, and as a sham intervention in the control (active comparator) group.\n\nThe study outcomes will be measured before, immediately after and at 6 months after biofeedback: 1) Clinical symptoms measured by scales during 7 consecutive days. 2) Responses to the probe meal: (a) sensations measured by scales; (b) changes in girth by adaptive belts; (c) diaphragmatic position by abdominal ultrasound.\n\nRelevance. The identification of a pathophysiological mechanism of dyspeptic symptoms could serve as an objective marker for diagnosis and as a target for the development of mechanistic treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rome IV Criteria for functional dyspepsia\n\nExclusion Criteria:\n\n* organic gastrointestinal diseases\n* obesity\n* history of anosmia and ageusia\n* alcohol abuse\n* eating disorders\n\nAge- and-sex-matched healthy subjects will be included in parallel to the 30 first patients, to determine the normal values of the response to the probe meal. Healthy subjects will not undergo the intervention.'}, 'identificationModule': {'nctId': 'NCT05417204', 'briefTitle': 'Abdominothoracic Muscular Tone in Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia', 'orgStudyIdInfo': {'id': 'PR(AG)163/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Correction of abnormal somatic response to a meal', 'description': 'Biofeedback in patients with functional dyspepsia and abnormal somatic response to a probe meal', 'interventionNames': ['Behavioral: Abdominothoracic biofeedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham intervention in patients with normal somatic response to a meal', 'description': 'Biofeedback in patients with functional dyspepsia and normal somatic response to a probe meal', 'interventionNames': ['Behavioral: Abdominothoracic biofeedback']}], 'interventions': [{'name': 'Abdominothoracic biofeedback', 'type': 'BEHAVIORAL', 'description': 'A standard biofeedback technique (3 sessions over a 4-week period) directed at controlling the muscular activity (postural tone) of the abdominal walls, will serve as active intervention in the experimental group, and as a sham intervention in the active comparator group.', 'armGroupLabels': ['Correction of abnormal somatic response to a meal', 'Sham intervention in patients with normal somatic response to a meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}