| NCT ID | NCT06369753 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-30 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Fernando Azpiroz, MD
PRINCIPAL INVESTIGATOR
University Hospital Vall d'Hebron
Frequently Asked Questions
Who can join the NCT06369753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06369753 currently recruiting?
Yes, NCT06369753 is actively recruiting participants. Contact the research team at azpiroz.fernando@gmail.com for enrollment information.
Where is the NCT06369753 trial being conducted?
This trial is being conducted at Los Angeles, United States, Hamilton, Canada, Bordeaux, France, Bologna, Italy and 3 additional locations.
Who is sponsoring the NCT06369753 clinical trial?
NCT06369753 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The principal investigator is Fernando Azpiroz, MD at University Hospital Vall d'Hebron. The trial plans to enroll 100 participants.