Recruiting

Biofeedback

Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Code:

NCT06369753

Conditions

Irritable Bowel Syndrome

Dyspepsia

Functional Bloating

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Biofeedback

Placebo

Study Details

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

Study ID

NCT06369753

Start date

Jul 30, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Biofeedback

placebo comparator: Placebo

Interventions

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.

Primary outcome measure

  • Visible abdominal distension [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

G. Oppenheimer Center for Neurobiology of Stress and Resilience

Recruiting

Los Angeles, California, United States, 90095

Contacts

McMaster University

Recruiting

Hamilton, Ontario, Canada, ON L8S 4L8

Contacts

More Information

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute on 2025-10-31.