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Visible Abdominal Distension
NCT06369753 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BEHAVIORAL Biofeedback
- BEHAVIORAL Placebo
Study Locations (7)
Other
- Bordeaux University Hospital — Bordeaux
- Santa Orsola Hospital — Bologna
- Hospital Universitari Vall d'Hebron — Barcelona
- Sahlgrenska Hospital, Gothenburg — Gothenburg
- Manchester University — Manchester
California
- G. Oppenheimer Center for Neurobiology of Stress and Resilience — Los Angeles
Ontario
- McMaster University — Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-07-30 |
| Est. Completion | 2026-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06369753
The ClinicalTrials.gov registry entry for NCT06369753 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital Universitari Vall d'Hebron Research Institute, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Biofeedback is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06369753 reports 7 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06369753 about?
NCT06369753 is a clinical study titled "Visible Abdominal Distension". 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. Howeve...
What is the current status of trial NCT06369753?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-07-30. Estimated completion is 2026-10.
What conditions does trial NCT06369753 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome, Dyspepsia, Functional Bloating. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06369753?
The interventions under investigation include: Biofeedback (BEHAVIORAL), Placebo (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06369753?
This trial is sponsored by Hospital Universitari Vall d'Hebron Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06369753 being conducted?
This trial has 7 study locations across California, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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