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Integrative Approaches to Managing Irritable Bowel Syndrome (IBS)

NCT02436603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-02-14

No results posted yet for this study

Summary

The purpose of this project is to examine whether a low cost, group-oriented integrative medicine approach to irritable bowel syndrome improves participant outcomes. The intervention will combine nutrition counseling on the low FODMAP diet (decreased grains and other disaccharides) and mind-body training with follow-up health coaching.

These participants will be randomized to either a 4-week group-oriented treatment intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health coaching follow-up period or a waitlist control group. At the end of the 12-week study period, waitlist subjects will be offered the four-week nutrition and mind-body intervention. Over the 12-week study period, we will examine and report on the impact of this treatment intervention on IBS symptoms and quality of life in this population. The investigators will collect data on IBS outcomes as well as on depression and stress.

Conditions

  • Irritable Bowel Syndrome
  • IBS

Interventions

BEHAVIORAL

Nutrition/Mind-Body Coaching

Following the four-week treatment intervention, participants will then be enrolled in an 8-week health coaching follow-up period. During this time participants will have a 45-60 minute telephone session with a health coach weekly for two weeks, then biweekly for four weeks.

Sponsors & Collaborators

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Elizabeth McDonald, MS,RD,CSS · The Center for Health & HealingDepartment of Integrative MedicineMount Sinai Beth Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-06-28
Completion
2017-06-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436603 on ClinicalTrials.gov