NCT02681666

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2017

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

August 17, 2015

Last Update Submit

June 8, 2018

Conditions

Abdominal PainIrritable Bowel SyndromeIBS

Keywords

FODMAP DietBowel HabitRome IV CriteriaMindfulnessAbdominal painIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (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.

    Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (3)

  • Change in score of IBS-Quality of Life questionnaire

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Change in score of Irritable Bowel Syndrome - Severity Scoring System

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Change in score in Perceived Stress Scale

    Baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

FODMAPs CONTROL arm

ACTIVE COMPARATOR

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

MB-IBS-EAT INTERVENTION STUDY arm

EXPERIMENTAL

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

Interventions

Dietary interventionDIETARY_SUPPLEMENT

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.

Also known as: FODMAPs Diet
FODMAPs CONTROL arm
Irritable Bowel Syndrome eating awareness trainingBEHAVIORAL

A type of meditation about their eating habits.

Also known as: MB-IBS-EAT
MB-IBS-EAT INTERVENTION STUDY arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Abdominal PainIrritable Bowel Syndrome

Interventions

Diet TherapyFODMAP Diet

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsElimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Daniel Sussman, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 17, 2015

First Posted

February 12, 2016

Study Start

July 1, 2017

Primary Completion

December 26, 2017

Study Completion

December 26, 2017

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

US(1)