Clinical trial NCT06369753: Visible Abdominal Distension
Official title: Tratamiento de la distensión Abdominal Funcional
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Dyspepsia
Functional Bloating
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visible abdominal distension
timeFrame: 4 weeks
Secondary outcomes:
measure: Sensation of abdominal pressure/fullness
timeFrame: 4 weeks
measure: Sensation of abdominal discomfort/pain
timeFrame: 4 weeks
Other outcomes:
measure: Follow-up after biofeedback
timeFrame: 6 months
Locations:
city: Los Angeles
country: United States
facility: G. Oppenheimer Center for Neurobiology of Stress and Resilience
state: California
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Bologna
country: Italy
facility: Santa Orsola Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Gothenburg
country: Sweden
facility: Sahlgrenska Hospital, Gothenburg
city: Manchester
country: United Kingdom
facility: Manchester University
Study officials:
affiliation: University Hospital Vall d'Hebron
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barba 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.