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Abdominal PainMB-IBS-EATNCT02681666

Mindfulness-Based Eating in Patients With Irritable Bowel Syndrome

A study testing Dietary intervention and Irritable Bowel Syndrome eating awareness training in people with Abdominal Pain and Irritable Bowel Syndrome, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Abdominal Pain, Irritable Bowel Syndrome, IBS
What is being tested?
Dietary intervention and Irritable Bowel Syndrome eating awareness training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Jul 2017to 26 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Dietary intervention, Irritable Bowel Syndrome eating awareness training
Keywords
FODMAP Diet, Bowel Habit, Rome IV Criteria, Mindfulness, Abdominal pain, Irritable Bowel Syndrome
Medical subject headings
Abdominal Pain, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary interventionDietary supplement

    Also called FODMAPs Diet

    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.

  • Irritable Bowel Syndrome eating awareness trainingBehavioural

    Also called MB-IBS-EAT

    A type of meditation about their eating habits.

Study groups in NCT02681666
Study groupRoleWhat they receive
FODMAPs CONTROL armActive comparatorDietary intervention in this cohort with irritable bowel syndrome will be administered a low Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet by a dietician.
Receives: Dietary Supplement: Dietary intervention
MB-IBS-EAT INTERVENTION STUDY armExperimentalIrritable Bowel Syndrome eating awareness training intervention will be started in a comprehensive 8 weekly sessions of Mindfulness eating training.
Receives: Behavioral: Irritable Bowel Syndrome eating awareness training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (3)
  1. 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]

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

  2. 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]

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

  3. Change in score in Perceived Stress Scale

    This questionnaire measures the degree to which situations in one's life are appraised as stressful.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2016 (estimated)
  2. Study start1 Jul 2017
  3. Primary completion26 Dec 2017
  4. Study completion26 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02681666
Sponsor's protocol ID
20150591
Acronym
MB-IBS-EAT
Status last verified
Jun 2018
First submitted
17 Aug 2015
Last updated
12 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Dietary intervention and Irritable Bowel Syndrome eating awareness training in people with Abdominal Pain and Irritable Bowel Syndrome, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Global Improvement Scale score (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.

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