DyspepsiaNCT05417204
Abdominothoracic Muscular Tone in Functional Dyspepsia
A study testing Abdominothoracic biofeedback in people with Dyspepsia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Abdominothoracic biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jul 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rome IV Criteria for functional dyspepsia
Who cannot join
- organic gastrointestinal diseases
- obesity
- history of anosmia and ageusia
- alcohol abuse
- eating disorders
- Age- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia
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.
Aim. To determine the role of the abdominothoracic muscular activity on symptoms of functional dyspepsia.
Read more
Design. 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.
Intervention. 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.
The 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.
Relevance. 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.
- Conditions
- Dyspepsia
- Being tested
- Abdominothoracic biofeedback
- Keywords
- Functional dyspepsia, Abdominal distension
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominothoracic biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Correction of abnormal somatic response to a meal | Experimental | Biofeedback in patients with functional dyspepsia and abnormal somatic response to a probe meal Receives: Behavioral: Abdominothoracic biofeedback |
| Sham intervention in patients with normal somatic response to a meal | Active comparator | Biofeedback in patients with functional dyspepsia and normal somatic response to a probe meal Receives: Behavioral: Abdominothoracic biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial fullness
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.
Measured: 7 days
Secondary outcomes (5)
Tolerance of a probe meal
Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.
Measured: 60 minutes
Digestive well-being after a probe meal
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
Measured: 60 minutes
Postprandial fullness after a probe meal
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
Measured: 60 minutes
Abdominal distension in response to a probe meal
Changes in the girth response to a probe meal (measured by adaptive belts) before and after intervention.
Measured: 60 minutes
Diaphragmatic response to a probe meal
Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start18 Jul 2022
- Primary completion31 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive design: a sample size calculation based on the primary outcome will be performed after 30 patients complete the post-intervention evaluation.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417204
- Sponsor's protocol ID
- PR(AG)163/2022
- Status last verified
- Oct 2024
- First submitted
- 8 Jun 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33670508
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05417204
- Acronym / sponsor ID
- PR(AG)163/2022
- Conditions
- Dyspepsia
- Keywords
- Functional dyspepsia, Abdominal distension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Aim. To determine the role of the abdominothoracic muscular activity on symptoms of functional dyspepsia.
Design. 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.
Intervention. 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.
The 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.
Relevance. 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Adaptive design: a sample size calculation based on the primary outcome will be performed after 30 patients complete the post-intervention evaluation.
| Arm | Type | Receives |
|---|---|---|
| Correction of abnormal somatic response to a meal | Experimental | Behavioral: Abdominothoracic biofeedbackBiofeedback in patients with functional dyspepsia and abnormal somatic response to a probe meal |
| Sham intervention in patients with normal somatic response to a meal | Active comparator | Behavioral: Abdominothoracic biofeedbackBiofeedback in patients with functional dyspepsia and normal somatic response to a probe meal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rome IV Criteria for functional dyspepsia
Key exclusion criteria (6 listed)
- organic gastrointestinal diseases
- obesity
- history of anosmia and ageusia
- alcohol abuse
- eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominothoracic biofeedbackA 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. | Behavioural | Correction of abnormal somatic response to a meal, Sham intervention in patients with normal somatic response to a meal |
Primary outcome
Postprandial fullness
Time frame: 7 days
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.
5 secondary outcomes
Tolerance of a probe meal
Time frame: 60 minutes
Digestive well-being after a probe meal
Time frame: 60 minutes
Postprandial fullness after a probe meal
Time frame: 60 minutes
Abdominal distension in response to a probe meal
Time frame: 60 minutes
Diaphragmatic response to a probe meal
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 33670508Livovsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominothoracic biofeedback in people with Dyspepsia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial fullness (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.