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NCT02436603 · ClinicalTrials.gov registry record · NA
Integrative Approaches to Managing Irritable Bowel Syndrome (IBS)
A NA study of Irritable Bowel Syndrome and IBS, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT02436603: Completed NA study of Irritable Bowel Syndrome and IBS, sponsored by Beth Israel Medical Center.
NCT02436603 is a NA study of Irritable Bowel Syndrome and IBS that has completed, run by Beth Israel Medical Center. The registered enrollment target is 52 participants, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02436603, a NA study of Irritable Bowel Syndrome and IBS, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Nutrition/Mind-Body Coaching
Study Locations (1)
New York
- Center for Health and Healing - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-04 |
| Est. Completion | 2017-06-28 |
| Phase | NA |
What the finished NCT02436603 record still lists
NCT02436603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Nutrition/Mind-Body Coaching is the first listed.
NCT02436603 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02436603 about?
NCT02436603 is a clinical study titled "Integrative Approaches to Managing Irritable Bowel Syndrome (IBS)". 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 tra...
What is the current status of trial NCT02436603?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2015-04. Estimated completion is 2017-06-28.
What conditions does trial NCT02436603 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome, IBS.
What interventions are being tested in trial NCT02436603?
The interventions under investigation include: Nutrition/Mind-Body Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT02436603?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02436603 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02436603's enrollment target sits among peer trials
52 32nd of 47 higher than 16 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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