Treatment of Constipation in Functional Dyspepsia

NCT02956187 | Completed

• 1 other identifier: PR(AG)181/2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dyspepsia; Constipation

Outcome Measures

Primary Outcomes (1)

• Change in clinical symptoms of functional dyspepsia during treatment versus before.

  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.

  4 weeks

Secondary Outcomes (1)

• Change in postprandial abdominal fullness measured after a test meal by the end of treatment versus before

  4 weeks

Study Arms (2)

Biofeedback for constipation

EXPERIMENTAL

Constipation will be treated by correcting functional outlet obstruction.

Behavioral: Biofeedback

Fiber supplementation

ACTIVE COMPARATOR

Constipation will be treated by a fiber supplement

Dietary Supplement: Fiber supplement

Interventions

Biofeedback BEHAVIORAL

Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.

Biofeedback for constipation

Fiber supplement DIETARY_SUPPLEMENT

3.5 g plantago ovata per day will be administered for 4 weeks.

Fiber supplementation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of organic gastrointestinal disorders
• Cognitive impairment.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Fernando Azpiroz

Barcelona, 08035, Spain

Location

Related Publications (1)

• Huaman JW, Mego M, Bendezu A, Monrroy H, Samino S, Accarino A, Saperas E, Azpiroz F. Correction of Dyssynergic Defecation, but Not Fiber Supplementation, Reduces Symptoms of Functional Dyspepsia in Patients With Constipation in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2463-2470.e1. doi: 10.1016/j.cgh.2019.11.048. Epub 2019 Dec 4.

  PMID: 31811952 DERIVED

MeSH Terms

Conditions

Dyspepsia; Constipation

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Fernando Azpiroz, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: November 7, 2016
• Study Start: June 12, 2016
• Primary Completion: December 10, 2017
• Study Completion: January 8, 2018
• Last Updated: January 19, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)