Biofeedback for Functional Abdominal Bloating

Recruiting at 6 trial locations

Overseen By Jordi Serra, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Disqualifiers: Organic cause, Constipation, others

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new biofeedback technique to help people with abdominal bloating. Biofeedback involves learning to control muscle activity, and here it aims to reduce belly swelling after meals. Participants will be divided into two groups: one will perform biofeedback exercises, and the other will receive a placebo (a fake treatment) for comparison. The trial seeks individuals who frequently experience visible stomach bloating after eating. As an unphased trial, this study explores innovative techniques that could enhance daily comfort and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biofeedback technique is safe for treating abdominal distension?

Research has shown that biofeedback can effectively reduce symptoms of abdominal bloating. In studies, biofeedback decreased muscle movements in the diaphragm and around the ribs, leading to less bloating and a smaller waistline. No serious side effects have been reported from using biofeedback.

Biofeedback is generally well-tolerated, meaning most people do not experience negative effects. Since it does not involve medication, it avoids many common drug-related side effects, making it a safe option for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Biofeedback is unique because it offers a non-drug approach to managing functional abdominal bloating, focusing on training patients to control physiological functions. Unlike standard treatments like dietary changes or medications that often target symptoms, biofeedback aims to address underlying physiological processes by helping patients become more aware of and better control their bodily responses. Researchers are excited about biofeedback because it could empower patients to manage their symptoms more effectively with fewer side effects, potentially leading to long-term relief.

What evidence suggests that this trial's treatments could be effective for abdominal distension?

Research has shown that biofeedback, a treatment in this trial, can greatly reduce belly swelling. One study found that participants using biofeedback experienced a 56% decrease in abdominal swelling. This technique helps individuals learn to control their stomach muscles, reducing visible bloating. It uses movements of the chest and stomach as signals to relax the muscles. This method has proven more effective than a placebo, another treatment arm in this trial, for treating belly swelling. Overall, biofeedback offers a promising solution for those dealing with uncomfortable bloating. ^{2 4 6 7 8}

Who Is on the Research Team?

Fernando Azpiroz, MD

Principal Investigator

University Hospital Vall d'Hebron

Are You a Good Fit for This Trial?

This trial is for individuals who experience visible abdominal bloating, particularly after eating. Participants should have symptoms consistent with conditions like Irritable Bowel Syndrome or indigestion that lead to this distension.

Inclusion Criteria

My belly visibly swells after I eat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either biofeedback or placebo intervention for abdominal distension

4 weeks

3 sessions in the first 3 weeks

Follow-up

Participants are monitored for sensation of abdominal distension at 1, 3, and 6 months after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Biofeedback
• Placebo

Trial Overview The study tests a noninstrumental biofeedback technique against a placebo. Biofeedback involves teaching patients to control their abdominal and thoracic muscles using video instructions, while the placebo group receives sham measurements and glucose pills.

How Is the Trial Designed?

Group I: Biofeedback Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Hospital Universitari Vall d'Hebron Research Institute

Lead Sponsor

Trials

253

Recruited

120,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1542356517308005

Correction of Abdominal Distention by Biofeedback-Guided ... Biofeedback resulted in a 56% ± 1% reduction of abdominal distention (from a mean score of 4.6 ± 0.2 to 2.0 ± 0.2), whereas patients in the placebo group had a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38467383/

Thoracoabdominal Wall Motion-Guided Biofeedback ... This study aimed to validate a simple biofeedback procedure, guided by abdominothoracic wall motion, for treating abdominal distention.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06150638

Treatment of Functional Abdominal Distension by Non- ... In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention.

4. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00285-3/fulltext

Thoracoabdominal Wall Motion–Guided Biofeedback ... Abdominothoracic wall movements serve as an effective biofeedback signal for correcting abdominophrenic dyssynergia and abdominal distention in patients with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6824367/

Bloating and Abdominal Distension: Clinical Approach and ... Biofeedback effectively diminished diaphragmatic and intercostal muscle contraction, decreasing both subjective bloating and abdominal girth [51] ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11357468/

Functional Abdominal Bloating and Gut Microbiota: An Update Bloating and distension affect approximately 30% of the general adult population [6], with a prevalence of FAB/FAD of approximately 3.5% and 1.2 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04043208

Treatment of Functional Abdominal Distension In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ueg2.70098

European Consensus on Functional Bloating and ... Results. Functional bloating and abdominal distension are common and frequently overlap with other disorders of gut-brain interaction.