Visible Abdominal Distension

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06369753
• 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. 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 noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.

Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and 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. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. 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: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• episodes of visible abdominal distension triggered by meal ingestion

Exclusion Criteria

• organic cause detected by clinical work-up
• constipation
• abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Biofeedback	Biofeedback	-

Primary Outcome Measures

Name	Time	Method
Visible abdominal distension	4 weeks	Distension 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
Sensation of abdominal discomfort/pain	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
Sensation of abdominal pressure/fullness	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.

Trial Locations

Locations (7)

G. Oppenheimer Center for Neurobiology of Stress and Resilience; 🇺🇸 Los Angeles, California, United States

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Santa Orsola Hospital; 🇮🇹 Bologna, Italy

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

Sahlgrenska Hospital, Gothenburg; 🇸🇪 Gothenburg, Sweden

Manchester University; 🇬🇧 Manchester, United Kingdom