Actively Recruiting
Visible Abdominal Distension
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-10-31
100
Participants Needed
7
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Visible Abdominal Distension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Episodes of visible abdominal distension triggered by meal ingestion
You will not qualify if you...
- Organic cause detected by clinical work-up
- Constipation
- Abdominal distension not confirmed by the 7-day clinical questionnaires in the pre-intervention evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
G. Oppenheimer Center for Neurobiology of Stress and Resilience
Los Angeles, California, United States, 90095
Actively Recruiting
2
McMaster University
Hamilton, Ontario, Canada, ON L8S 4L8
Actively Recruiting
3
Bordeaux University Hospital
Bordeaux, France, 33000
Active, Not Recruiting
4
Santa Orsola Hospital
Bologna, Italy, 40138
Active, Not Recruiting
5
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
6
Sahlgrenska Hospital, Gothenburg
Gothenburg, Sweden, 413 45
Active, Not Recruiting
7
Manchester University
Manchester, United Kingdom, M14 9PR
Active, Not Recruiting
Research Team
F
Fernando Azpiroz, MD
CONTACT
J
Jordi Serra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here