Visible Abdominal Distension

NCT06369753 | Recruiting

• 1 other identifier: PR(AG)459/2023B
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 7

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.

Conditions

Irritable Bowel Syndrome; Dyspepsia; Functional Bloating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensation of abdominal pressure/fullness

  4 weeks

• Sensation of abdominal discomfort/pain

  4 weeks

Other Outcomes (1)

• Follow-up after biofeedback

  6 months

Study Arms (2)

Biofeedback

EXPERIMENTAL

Behavioral: Biofeedback

Placebo

PLACEBO COMPARATOR

Behavioral: Placebo

Interventions

Biofeedback BEHAVIORAL

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

Biofeedback

Placebo BEHAVIORAL

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• episodes of visible abdominal distension triggered by meal ingestion

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (7)

G. Oppenheimer Center for Neurobiology of Stress and Resilience

Los Angeles, California, 90095, United States

RECRUITING

McMaster University

Hamilton, Ontario, ON L8S 4L8, Canada

RECRUITING

Bordeaux University Hospital

Bordeaux, 33000, France

ACTIVE NOT RECRUITING

Santa Orsola Hospital

Bologna, 40138, Italy

ACTIVE NOT RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Sahlgrenska Hospital, Gothenburg

Gothenburg, 413 45, Sweden

ACTIVE NOT RECRUITING

Manchester University

Manchester, M14 9PR, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (2)

• 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.

  PMID: 38467383 BACKGROUND

• 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.

  PMID: 28705783 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dyspepsia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Fernando Azpiroz, MD

  University Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Azpiroz, MD

CONTACT

34 932746259; azpiroz.fernando@gmail.com

Jordi Serra, MD

CONTACT

34 932746259; jordi.serra@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: July 30, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

SE (1); US (1); GB (1); CA (1); ES (1); IT (1); FR (1)