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

Trial Summary

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 data supports the effectiveness of the treatment Biofeedback for Functional Abdominal Bloating?

Research suggests that biofeedback therapy, particularly pelvic floor biofeedback, can be effective for severe bloating in patients with disorders of gut-brain interaction, especially when there is outlet dysfunction. ^{1 2 3 4 5}

Is biofeedback therapy safe for treating abdominal bloating?

Biofeedback therapy, used for conditions like abdominal bloating, is generally considered safe for humans. It is a non-invasive treatment that helps patients learn to control bodily functions, and no significant safety concerns have been reported in the available research. ^{1 2 3 4 6}

How does biofeedback treatment for functional abdominal bloating differ from other treatments?

Biofeedback treatment for functional abdominal bloating is unique because it focuses on retraining the body's response to abdominal distension by correcting abdomino-phrenic dysynergia (a lack of coordination between the diaphragm and abdominal muscles), which can help reduce bloating and distension. This approach is different from other treatments that primarily target gas production or gut motility through dietary changes or medications. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Fernando Azpiroz, MD

Principal Investigator

University Hospital Vall d'Hebron

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Towards a better understanding of abdominal bloating and distension in functional gastrointestinal disorders. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Abdominal bloating. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Pelvic floor biofeedback is an effective treatment for severe bloating in disorders of gut-brain interaction with outlet dysfunction. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Management of bloating. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Bloating and functional gastro-intestinal disorders: where are we and where are we going? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation. [2017]

7. Italy pubmed.ncbi.nlm.nih.gov

Colonic gas transit in patients with bloating: the effect of an electromechanical stimulator of the abdominal wall. [2021]