Irritable Bowel Syndrome Clinical Trial
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.
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.
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