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Search / Trial NCT05630703

Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 25, 2022

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Irritable Bowel Syndrome (Ibs) Mindfulness Fodmap

ClinConnect Summary

This clinical trial is exploring two different approaches to help people with Irritable Bowel Syndrome (IBS) manage their symptoms. One group of participants will receive mindfulness training, which involves techniques to help them focus on the present moment and reduce stress. The other group will follow a specific diet known as the low FODMAP diet, which limits certain types of carbohydrates that can trigger IBS symptoms. The goal is to see which method is more effective in improving the quality of life for those suffering from IBS.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of IBS based on specific criteria. You should also be able to understand and sign consent forms, and have access to a computer or smart device for online sessions. However, individuals who are pregnant, have certain medical conditions, or have a history of eating disorders are not eligible. The trial is currently not recruiting participants, but if you qualify, you can expect to engage in either the mindfulness training or the dietary program and share your experiences to help researchers learn more about these approaches for managing IBS.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 18 and over
  • Meets Rome IV criteria for diagnosis of Irritable Bowel Syndrome (IBS)
  • Has legal and mental capacity to understand and sign an informed consent document
  • Access to a computer or smart device with internet
  • Exclusion Criteria:
  • Pregnancy
  • Active malignancy in the previous five years
  • Current or prior history of alcohol or drug abuse as defined by clinician
  • Any history of eating disorder such as anorexia or bulimia
  • Taking yoga or with prior history of mindfulness therapy within 3 months of enrollment
  • Currently on a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
  • Psychiatric illnesses other than depression or anxiety disorder
  • Nausea or vomiting

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Charlotte, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Baharak Moshiree, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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