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NCT06369753 · ClinicalTrials.gov registry record · NA
Visible Abdominal Distension
A NA study of Irritable Bowel Syndrome and Dyspepsia, sponsored by Hospital Universitari Vall d'Hebron Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 7
- Study locations
NCT06369753: Recruiting NA study of Irritable Bowel Syndrome and Dyspepsia, sponsored by Hospital Universitari Vall d'Hebron Research Institute.
NCT06369753 is a NA study of Irritable Bowel Syndrome and Dyspepsia that is actively recruiting participants, run by Hospital Universitari Vall d'Hebron Research Institute. The registered enrollment target is 100 participants, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (30% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06369753, a NA study of Irritable Bowel Syndrome and Dyspepsia, is actively recruiting participants, sponsored by Hospital Universitari Vall d'Hebron Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Distension score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.
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 |
What NCT06369753 shows while recruiting
NCT06369753 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (30% lower).
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.
NCT06369753 lists 7 locations in 3 states (Other, California, Ontario).
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.
What interventions are being tested in trial NCT06369753?
The interventions under investigation include: Biofeedback (BEHAVIORAL), Placebo (BEHAVIORAL).
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.
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.
Learn More About Clinical Trials
Similar trials for Irritable Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06369753's enrollment target sits among peer trials
100 21st of 47 higher than 27 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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