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

Wake Forest University (WFU)

Status: Begins enrollment this month

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Other: Low FODMAP Diet; Behavioral: Mindfulness-based Attention Training in IBS

Study type: Interventional

Funder types: Other

Identifiers

NCT05630703

07-19-15E (Other Identifier)

IRB00083217

Details and patient eligibility

About

The study aims to compare the effect of mindfulness-based awareness training in Irritable Bowel Syndrome (IBS) (MB-IBS-EAT) with the dietary standard of care (low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet) on patient's IBS symptoms

Full description

This pilot study will be a randomized parallel trial comparing MB-IBS-EAT done over an 8-week period to a standard low FODMAP diet. The low FODMAP diet is currently employed by clinicians as a treatment for IBS, but response rates are poor, without documented long-term benefit. This finding supports the need for better, longer lasting interventions.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Mindfulness Training

Experimental group

Description:

Behavioral: Mindfulness-based Eating Awareness Training in IBS - The MB-IBS-EAT is an 8-week intervention with weekly 1-hour sessions in a web-based group format.

Treatment:

Behavioral: Mindfulness-based Attention Training in IBS

fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet

Active Comparator group

Description:

Dietary: Low FODMAP Diet - Subjects in the FODMAP group will be provided dietary instructions by a registered dietician during weekly 1-hour sessions in a web-based group format.

Treatment:

Other: Low FODMAP Diet