Constipation, Dyspepsia
Conditions
Brief summary
Background. Functional dyspepsia is characterized by symptoms that apparently originate in the stomach without detectable cause by conventional diagnosis test. The pathophysiology of functional dyspepsia is not known, but a number of data indicate that dyspeptic patients have increased sensitivity of the digestive system, so that physiological stimuli may induce their symptoms. Some patients with functional dyspepsia have also functional constipation and the investigators hypothesize that in them constipation triggers or facilitates dyspeptic symptoms, and consequently, correction of constipation relieves dyspeptic symptoms. Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the treatment of dyspeptic symptoms in patients with constipation due to functional outlet obstruction. Design. Randomized, controlled parallel trial performed in a referral center. Participants. Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet obstruction. Interventions: Patients will be assigned to experimental (biofeedback for functional outlet obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during the first 3 weeks of the intervention period) combined with instructions for daily exercising for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks. Main outcome and measures. Clinical symptoms of functional dyspepsia measured by daily questionnaires for 7 consecutive days before and during the last week of intervention. Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a diverse group of conditions with different pathophysiology. As a result, the treatment is empirical and globally inefficient. This study will identify a subset of patients with a common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction) which respond to specific treatment (biofeedback).
Interventions
BEHAVIORALBiofeedback
Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.
DIETARY_SUPPLEMENTFiber supplement
3.5 g plantago ovata per day will be administered for 4 weeks.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with functional dyspepsia and functional constipation. Inclusion Criteria * Rome IV criteria for functional dyspepsia type of postprandial distress syndrome. * Rome IV criteria of functional constipation * Anorectal manometry showing defective sphincter relaxation during the defecatory manoeuver.
Exclusion criteria
* History of organic gastrointestinal disorders * Cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical symptoms of functional dyspepsia during treatment versus before. | 4 weeks | Change in average postprandial abdominal fullness measured daily by 0-10 score scales for 7 consecutive days before and during the last week of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in postprandial abdominal fullness measured after a test meal by the end of treatment versus before | 4 weeks | Change in average postprandial abdominal fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention. |
Countries
Spain
Outcome results
None listed