Visible Abdominal Distension

Irritable Bowel Syndrome Clinical Trial

Official title:

Tratamiento de la distensión Abdominal Funcional

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369753
• Other study ID #: PR(AG)459/2023B
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Fernando Azpiroz, MD
• Phone: 34 932746259
• Email: azpiroz.fernando[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Irritable Bowel Syndrome

Intervention

Behavioral:
• Biofeedback
Three sessions of biofeedback intervention will be performed during the first 3 weeks of the intervention period. 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
Three sessions of placebo intervention will be performed during the first 3 weeks of the intervention period. 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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.201 — View Citation

Barba E, Livovsky DM, Accarino A, Azpiroz F. THORACOABDOMINAL WALL MOTION-GUIDED BIOFEEDBACK TREATMENT OF ABDOMINAL DISTENSION: A RANDOMIZED PLACEBO-CONTROLLED TRIAL. Gastroenterology. 2024 Mar 9:S0016-5085(24)00285-3. doi: 10.1053/j.gastro.2024.03.005. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow-up after biofeedback	Sensation of abdominal distension 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 at 1, 3 and 6 months after biofeedback treatment	6 months
Primary	Visible abdominal distension	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.	4 weeks
Secondary	Sensation of abdominal pressure/fullness	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.	4 weeks
Secondary	Sensation of abdominal discomfort/pain	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	4 weeks