Irritable Bowel SyndromeNCT04043208
Treatment of Functional Abdominal Distension
A study testing Biofeedback in people with Irritable Bowel Syndrome and Dyspepsia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Background. Abdominal distention is produced by an abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome, Dyspepsia
- What is being tested?
- Biofeedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jul 2019to 17 Jan 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- episodes of visible abdominal distension triggered by meal ingestion
- patients are able to identify the offending foodstuff
Who cannot join
- organic cause detected by clinical work-up
- constipation
- abdominal distension not confirmed by the 7-day clinical questionnaires of after the probe meal in the pre-intervention evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tratamiento de la Distension Abdominal Funcional
Background. Abdominal distention is produced by an abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.
Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of abdominal distension.
Read more
Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal.
Intervention. Patients will be randomized into biofeedback in placebo groups.Three sessions of either biofeedback or placebo intervention will be performed 30 min after ingestion of the offending meal during the first 3 weeks of the intervention period.
Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth); patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Primary Outcome Measure:
Effect of the probe meal on the activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) measured by electromyography before and after the probe meal. The response to the probe meal will be measured before and after treatment.
Secondary Outcome Measures:
- Effect of the probe meal on sensation of abdominal distension measured by 0-6 scales after the probe meal.
- Changes in girth produced by the probe meal measured using a non-stretch belt placed over the umbilicus before and after the probe meal.
- Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
- Conditions
- Irritable Bowel Syndrome, Dyspepsia
- Being tested
- Biofeedback, Placebo
- Medical subject headings
- Irritable Bowel Syndrome, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Three sessions of biofeedback will be performed during the first 3 weeks of the intervention period. Biofeedback sessions will be performed 30 min after ingestion of the offending meal: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth). Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
PlaceboDietary supplement
Three sessions will be performed during the first 3 weeks of the intervention period. Each session will be performed 30 min after ingestion of the offending meal: abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | Not described Receives: Behavioral: Biofeedback |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the probe meal on thoraco-abdominal activity of the muscular walls.
Activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) will be measured by electromyography before and after the probe meal. The response to the meal will be measured before and after treatment.
Measured: 4 weeks
Secondary outcomes (4)
Effect of the probe meal on sensation of abdominal distension
Sensation score measured by 0-6 scales after the probe meal.The response to the meal will be measured before and after treatment.
Measured: 4 weeks
Changes in girth produced by the probe meal
Abdominal girth will be measured using a non-stretch belt that is placed over the umbilicus before and after the probe meal.The response to the meal will be measured before and after treatment.
Measured: 4 weeks
Sensation of abdominal distension
Sensation score measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
Measured: 4 weeks
Follow-up after biofeedback
Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period at 1, 3 and 6 months after biofeedback treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start25 Jul 2019
- Primary completion19 Jan 2021
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043208
- Sponsor's protocol ID
- PR(AG)377/2018
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barba E, Accarino A, Azpiroz F. Correction of Abdominal Distention by Biofeedback-Guided Control of Abdominothoracic Muscular Activity in a Randomized, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1922-1929. doi: 10.1016/j.cgh.2017.06.052. Epub 2017 Jul 11.
PubMed 28705783Barba E, Livovsky DM, Accarino A, Azpiroz F. Thoracoabdominal Wall Motion-Guided Biofeedback Treatment of Abdominal Distention: A Randomized Placebo-Controlled Trial. Gastroenterology. 2024 Aug;167(3):538-546.e1. doi: 10.1053/j.gastro.2024.03.005. Epub 2024 Mar 11.
PubMed 38467383
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tratamiento de la Distension Abdominal Funcional
- ClinicalTrials.gov ID
- NCT04043208
- Acronym / sponsor ID
- PR(AG)377/2018
- Conditions
- Irritable Bowel Syndrome, Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 2 Aug 2019 (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. Abdominal distention is produced by an abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.
Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of abdominal distension.
Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal.
Intervention. Patients will be randomized into biofeedback in placebo groups.Three sessions of either biofeedback or placebo intervention will be performed 30 min after ingestion of the offending meal during the first 3 weeks of the intervention period.
Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth); patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Primary Outcome Measure:
Effect of the probe meal on the activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) measured by electromyography before and after the probe meal. The response to the probe meal will be measured before and after treatment.
Secondary Outcome Measures:
- Effect of the probe meal on sensation of abdominal distension measured by 0-6 scales after the probe meal.
- Changes in girth produced by the probe meal measured using a non-stretch belt placed over the umbilicus before and after the probe meal.
- Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: Biofeedback |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- episodes of visible abdominal distension triggered by meal ingestion
- patients are able to identify the offending foodstuff
Key exclusion criteria (3 listed)
- organic cause detected by clinical work-up
- constipation
- abdominal distension not confirmed by the 7-day clinical questionnaires of after the probe meal in the pre-intervention evaluation
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 |
|---|---|---|
| BiofeedbackThree sessions of biofeedback will be performed during the first 3 weeks of the intervention period. Biofeedback sessions will be performed 30 min after ingestion of the offending meal: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth). Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. | Behavioural | Biofeedback |
| PlaceboThree sessions will be performed during the first 3 weeks of the intervention period. Each session will be performed 30 min after ingestion of the offending meal: abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. | Dietary supplement | Placebo |
Primary outcome
Effect of the probe meal on thoraco-abdominal activity of the muscular walls.
Time frame: 4 weeks
Activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) will be measured by electromyography before and after the probe meal. The response to the meal will be measured before and after treatment.
4 secondary outcomes
Effect of the probe meal on sensation of abdominal distension
Time frame: 4 weeks
Changes in girth produced by the probe meal
Time frame: 4 weeks
Sensation of abdominal distension
Time frame: 4 weeks
Follow-up after biofeedback
Time frame: 6 months
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 22 Feb 2022.
- Results publication: PubMed 28705783Barba E, Accarino A, Azpiroz F. Correction of Abdominal Distention by Biofeedback-Guided Control of Abdominothoracic Muscular Activity in a Randomized, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1922-1929. doi: 10.1016/j.cgh.2017.06.052. Epub 2017 Jul 11.
- Derived from this study: PubMed 38467383Barba E, Livovsky DM, Accarino A, Azpiroz F. Thoracoabdominal Wall Motion-Guided Biofeedback Treatment of Abdominal Distention: A Randomized Placebo-Controlled Trial. Gastroenterology. 2024 Aug;167(3):538-546.e1. doi: 10.1053/j.gastro.2024.03.005. Epub 2024 Mar 11.
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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 Biofeedback in people with Irritable Bowel Syndrome and 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 2 inclusion and 3 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 22 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Effect of the probe meal on thoraco-abdominal activity of the muscular walls. (time frame: 4 weeks). 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 NCT04043208, which also lists 2 linked publications.
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 22 Feb 2022.