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NCT06150638
Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback
NA trial testing Biofeedback in Irritable Bowel Syndrome in 41 participants. Completed in 14 July 2025.
8 December 2024
Quick facts
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 29 April 2024 |
| Primary completion | 8 December 2024 |
| Estimated completion | 14 July 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Biofeedback
- Placebo
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
- Dyspepsia — all drugs for Dyspepsia →
- Functional Bloating — all drugs for Functional Bloating →
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Who can join
Adults 18 to 80, any sex, with Irritable Bowel Syndrome or Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. 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 non-instrumental biofeedback technique for the treatment of abdominal distension. Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal. Intervention. Patients will be randomized into biofeedback in 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. 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
- PubMed search for NCT06150638
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06150638 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute
- Last refreshed: 25 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06150638.
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