Mindfulness-Based Eating in Patients With Irritable Bowel Syndrome (MB-IBS-EAT)

A Pilot, Randomized Trial of Mindfulness-based Irritable Bowel Syndrome Eating Awareness Training as Compared to the Standard Low Fermentable Oligosaccharide, Disaccharide, Monosaccharide and Polyol Diet in Patients With IBS

This pilot study will be a randomized parallel trial comparing Mindfulness-Based Irritable Bowel Syndrome Eating Awareness Training done over an 8 week period to a standard low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Abdominal Pain; IBS
• Intervention / Treatment: Dietary supplement: Dietary intervention; Behavioral: Irritable Bowel Syndrome eating awareness training

Detailed Description

This study is supported by findings that Irritable Bowel Syndrome patients have an alteration of the hypothalamus-pituitary-adrenal stress axis such that cortisol levels are elevated. Stress-induced release of corticotropin-releasing factor alters gastric digestion and gastrointestinal motility. Furthermore, stress is a contributing factor to the immune activation and low-grade inflammation observed in Irritable Bowel Syndrome with overall physical and psychological distress correlating with percentage of activated natural killer and T cells. In addition, the brain-gut axis is a proposed mechanism in Irritable Bowel Syndrome due to dysregulated enteric nervous system and central nervous system events. The central nervous system may perceive visceral stimuli from the gut mucosa when inflammation or injury causes afferent nerve sensitization.

Regardless of the specific pathophysiologic basis of Irritable Bowel Syndrome, the current aim of treatment is to improve quality of life, treatments include dietary alterations and psychological therapy such as cognitive behavioral therapy to aid symptomatic relief. The most common dietary intervention in patients with Irritable Bowel Syndrome is the fermentable oligosaccharide, disaccharide, monosaccharide and polyol restricted diet. However, adherence to this diet is very difficult with most patients with Irritable Bowel Syndrome failing to continue eliminating foods leading to bloating or pain. Various psychological therapies have been implemented in the past with the most successful of these being cognitive behavioral therapy. The beneficial results of incorporating mindfulness-based interventions to improve myriad health-related problems, such as Irritable Bowel Syndrome, anxiety disorders , psychological distress, quality of life, depression fibromyalgia , diabetes , and eating disorders has grown considerably in the recent past. Mindfulness Based Eating Awareness Training, which was developed based on Jon Kabat-Zinn's Mindfulness Based Stress Reduction program, has been shown to improve binge eating disorder and other food and stress-related problems. The effect of Mindfulness Based Eating Awareness Training is driven by the improved ability of practitioners to increase engagement in non-judgmental self-awareness behaviors designed to improve regulatory impulses and stress reactivity as well as to nurture awareness of emotional status and outside triggers. The investigators have developed a 12 week Mindfulness-Based Irritable Bowel Syndrome Eating Awareness Training inspired by relevant pieces of the Mindfulness Based Eating Awareness Training program. Mindfulness based interventions integrate moment by moment awareness of bodily sensations, observations, thoughts, and feelings while suspending judgments of self. Successful Irritable Bowel Syndrome treatment modalities have been elusive, but have a strong food and stress-reactive association making this medical condition ideal for a mindfulness treatment intervention. The usual diet for Irritable Bowel Syndrome is an elimination diet of fermentable carbohydrates (of varying sugar lengths) and polyols (sugar alcohols and stone fruits) called the Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols elimination diet. Patients with Irritable Bowel Syndrome who follow a Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet receive suboptimal nutrient intake over long time periods while attempting to discern which food groups are digestible and which others are intolerable, with mixed findings of improvement in quality of life, and other stress-related measures.

After eligibility is established, written informed consent will be obtained and randomization will be conducted to place participants in either the mindfulness-based Irritable Bowel Syndrome- eating awareness training group or the Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols group and pre-baseline testing will be performed on both groups. Two-four weeks later participants will receive baseline testing at their first session of both arms of the study. Four weeks later, participants in both study arms will receive a follow up assessment testing. Directly following the eight week intervention or Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols arm, participants will receive post-intervention testing 1.

At 2 and 4 weeks following the intervention or Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols FODMAPs) arm, post-intervention testing 2 and post-intervention testing 3 will take place, respectively for a total of 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Subjects aged 18 and over
• Meet Rome III criteria for diagnosis of Irritable Bowel Syndrome
• Subjects with legal and mental capacity to understand and sign an informed consent.

Exclusion criteria: The following subjects will be excluded from the study:

• Pregnant patients
• Subjects with active malignancy in the previous five years
• Current or prior history of alcohol or drug abuse
• Any history of eating disorder such as anorexia or bulimia
• Subjects taking yoga or with prior history of mindfulness therapy within 3 months of enrolment
• Subjects currently on a FODMAP diet.
• Patients with psychiatric illnesses other than depression or anxiety disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FODMAPs CONTROL arm; Dietary intervention in this cohort with irritable bowel syndrome will be administered a low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet by a dietician.	Dietary supplement: Dietary intervention; Sessions will be spent with patients discussing the FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet and how to use this diet to treat their Irritable Bowel Syndrome.; Other Names: FODMAPs Diet
Experimental: MB-IBS-EAT INTERVENTION STUDY arm; Irritable Bowel Syndrome eating awareness training intervention will be started in a comprehensive 8 weekly sessions of Mindfulness eating training.	Behavioral: Irritable Bowel Syndrome eating awareness training; A type of meditation about their eating habits.; Other Names: MB-IBS-EAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Improvement Scale score	This questionnaire provides an overall assessment of how much a patient's symptoms and behaviors have improved or worsened since the start of treatment.	Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score of IBS-Quality of Life questionnaire	This questionnaire is a 34-item instrument developed and validated for measurement of health-related quality of life in non-subtyped IBS patients. [doi: 10.1186/1477-7525-11-208]	Baseline, 4 weeks, 8 weeks, 12 weeks
Change in score of Irritable Bowel Syndrome - Severity Scoring System	"This scale evaluates primarily the intensity of IBS symptoms during a 10-day period: abdominal pain, distension, stool frequency and consistency, and interference with life in general. The IBS-SSS calculates the sum of these 5 items each scored on a visual analog scale from 0 to 100." [doi:10.1038/ajg.2011.201]	Baseline, 4 weeks, 8 weeks, 12 weeks
Change in score in Perceived Stress Scale	This questionnaire measures the degree to which situations in one's life are appraised as stressful.	Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Daniel Sussman, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 26, 2017
• Study Completion (Actual): December 26, 2017

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Mindfulness; Abdominal pain; Rome IV Criteria; FODMAP Diet; Bowel Habit
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Abdominal Pain
• Other Study ID Numbers: 20150591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No