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Treatment of Functional Abdominal Distension

Tratamiento de la Distension Abdominal Funcional

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04043208
Enrollment
32
Registered
2019-08-02
Start date
2019-07-25
Completion date
2022-01-17
Last updated
2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Irritable Bowel Syndrome

Brief 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. 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.

Interventions

BEHAVIORALBiofeedback

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.

DIETARY_SUPPLEMENTPlacebo

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.

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* episodes of visible abdominal distension triggered by meal ingestion * patients are able to identify the offending foodstuff

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Effect of the probe meal on thoraco-abdominal activity of the muscular walls.4 weeksActivity 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.

Secondary

MeasureTime frameDescription
Effect of the probe meal on sensation of abdominal distension4 weeksSensation score measured by 0-6 scales after the probe meal.The response to the meal will be measured before and after treatment.
Changes in girth produced by the probe meal4 weeksAbdominal 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.
Sensation of abdominal distension4 weeksSensation 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.
Follow-up after biofeedback6 monthsSensation 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026