Integrative Approaches to Managing Irritable Bowel Syndrome (IBS)
1 other identifier
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2017
CompletedFebruary 14, 2018
February 1, 2018
2.2 years
April 28, 2015
February 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
IBS Symptom Severity Scale
a validated tool which is currently the gold standard for evaluating interventions for IBS. Change in IBS Symptom Severity Scale at week 12 as compared to Baseline
Baseline and week 12
IBS Quality of Life (IBS-QOL)
Change in IBS-QOL at week 12 as compared to Baseline
Baseline and Week 12
Secondary Outcomes (2)
Patient Global Impression of Change (PGIC)
Baseline and Week 12
Perceived Stress Scale (PSS)
Baseline and Week 12
Other Outcomes (1)
Center for Epidemiological Studies - Depression Scale (CES-D)
Baseline and Week 12
Study Arms (2)
Nutrition/Mind-Body Coaching
OTHERThe intervention will consist of weekly group sessions lasting 75-90 minutes during which participants will receive training in the FODMAP diet and mind-body skills.
Waitlist Control Group
NO INTERVENTIONWaitlist subjects. At the end of the 12-week study period, waitlist subjects will be offered the four-week nutrition and mind-body intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- IBS diagnosis\> 12 months in duration
- Over 18 years of age
- English speaking
You may not qualify if:
- Active major psychiatric illness which would potentially interfere with participation in the study 2. Pregnancy 3. Active eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Health and Healing
New York, New York, 10016, United States
Related Publications (1)
Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis and treatment: an update for health-care practitioners. J Gastroenterol Hepatol. 2010 Apr;25(4):691-9. doi: 10.1111/j.1440-1746.2009.06120.x. Epub 2010 Jan 13.
PMID: 20074154BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth McDonald, MS,RD,CSS
The Center for Health & HealingDepartment of Integrative MedicineMount Sinai Beth Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 7, 2015
Study Start
April 1, 2015
Primary Completion
June 28, 2017
Study Completion
June 28, 2017
Last Updated
February 14, 2018
Record last verified: 2018-02