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Visible Abdominal Distension

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 31, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Jul 30, 2025
    • Site details revised at 7 of 7 sites
    • Publications: details revised at 1 of 2 entries
    v7
  2. Notable Start date: May 2025 to Jul 2025
    • Site contacts updated at 2 of 7 sites
    v6
  3. Minor Study sites: 2 to 7v5
  4. Minor Study sites: 1 to 2
    • Start date: Apr 2025 to May 2025
    • Publications: details revised at 1 of 2 entries
    v4
  5. Notable Primary completion date: May 2025 to Apr 2026
    • Start date: Dec 2024 to Apr 2025
    • Study completion date: Jul 2025 to Oct 2026
    v3
  6. Notable Start date: Sep 2024 to Dec 2024v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06369753
Lead Sponsor Hospital Universitari Vall d'Hebron Research Institute
Conditions
(from sponsor)
Irritable Bowel Syndrome, Dyspepsia, Functional Bloating
Related terms Dyspepsia, Irritable Bowel Syndrome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov