Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback

Not Applicable

Active, not recruiting

• Conditions: Irritable Bowel Syndrome; Dyspepsia; Functional Bloating
• Interventions: Behavioral: Biofeedback; Behavioral: Placebo

• Registration Number: NCT06150638
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial the authors 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 non-instrumental 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 during the first 3 weeks of the intervention period.

Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-29
• Study Start: 2024-04-29
• Primary Completion: 2024-12-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Study Completion: 2025-07-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

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 or after the probe meal in the pre-intervention evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback	Biofeedback	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sensation of abdominal distension	4 weeks	Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.

Secondary Outcome Measures

Name	Time	Method
Changes in girth produced by the probe meal	4 weeks	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.
Effect of probe meal on sensation of abdominal distension	4 weeks	Sensation score measured by scales graded from 0 (not at all) to 10 (very much) after the probe meal. The response to the meal will be measured before and after the intervention.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain