Mindfulness Training vs. Low FODMAP Diet for Irritable Bowel Syndrome

(FODMAP Trial)

Overseen By Jamie Crawford, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy, Active malignancy, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two approaches to managing Irritable Bowel Syndrome (IBS) symptoms. It compares mindfulness training, which increases awareness and reduces stress, with a low FODMAP diet, known to ease digestive issues by eliminating certain carbs. Participants will engage in weekly online sessions for either mindfulness or diet guidance. Those diagnosed with IBS who are not currently on a low FODMAP diet or practicing mindfulness might be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore effective IBS management strategies tailored to individual needs.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness training is generally safe for people with Irritable Bowel Syndrome (IBS). Studies have found that it can significantly reduce IBS symptoms without major safety concerns. Participants in mindfulness programs often experience less abdominal pain and improved quality of life, with no serious side effects reported.

Regarding the low FODMAP diet, research indicates it is safe for people with IBS. Studies have shown that about 50% to 80% of those who follow this diet experience fewer symptoms. Importantly, when guided by a dietitian, this diet does not lead to significant nutritional deficiencies or health issues.

Both mindfulness training and the low FODMAP diet are generally safe and positively affect IBS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for irritable bowel syndrome (IBS) because they offer alternatives to traditional approaches like medication and general dietary changes. The Low FODMAP Diet is distinctive because it targets specific carbohydrates that can trigger IBS symptoms, providing personalized dietary guidance to help manage discomfort. Meanwhile, Mindfulness-based Attention Training is unique as it addresses the psychological aspects of IBS, using mindfulness techniques to help patients manage stress and improve their relationship with food. These approaches not only offer potential relief from IBS symptoms but also empower patients with tools to manage their condition beyond conventional treatment options.

What evidence suggests that this trial's treatments could be effective for IBS?

This trial will compare the effectiveness of mindfulness training and a low FODMAP diet in treating symptoms of Irritable Bowel Syndrome (IBS). Research has shown that both mindfulness training and a low FODMAP diet can help manage IBS symptoms. Participants in the mindfulness training arm may experience reduced bowel symptom severity and improved mental health. Meanwhile, those in the low FODMAP diet arm may find relief from symptoms like stomach pain and bloating, with studies showing effectiveness for up to 86% of IBS patients. Both methods offer promising ways to manage IBS, each with its own strengths in addressing the condition's symptoms. ^{3 6 7 8 9}

Who Is on the Research Team?

Baharak Moshiree, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Irritable Bowel Syndrome (IBS) who can access the internet and understand consent forms. It's not for those already on a low FODMAP diet, with certain psychiatric conditions (excluding depression/anxiety), cancer in the last 5 years, eating disorders, pregnant women, or substance abuse history.

Inclusion Criteria

Access to a computer or smart device with internet

I have been diagnosed with IBS according to Rome IV criteria.

I can legally and mentally understand and sign a consent form.

Exclusion Criteria

Pregnancy

I have been practicing yoga or mindfulness therapy in the last 3 months.

Currently on a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week intervention with weekly 1-hour sessions in a web-based group format, either receiving Mindfulness-based Eating Awareness Training or following a low FODMAP diet.

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in various health metrics, including serotonin levels, IBS symptoms, and quality of life.

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Low FODMAP Diet
• Mindfulness-based Attention Training in IBS

Trial Overview

The study compares mindfulness-based attention training specifically designed for IBS against a low FODMAP diet to see which better alleviates IBS symptoms. Participants will either learn mindfulness techniques or follow a strict dietary plan.

How Is the Trial Designed?

Group I: Mindfulness Training Experimental Treatment 1 Intervention

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.

Group II: fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Restricting dietary FODMAPs has been shown to improve symptoms like abdominal pain and bloating in over half of IBS patients, highlighting its efficacy as a treatment option.

There is potential for developing personalized dietary therapies based on individual sensitivities to FODMAPs, which could lead to more effective and less restrictive dietary plans for IBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of diet in the management of irritable bowel syndrome: a focus on FODMAPs. Dolan, R., Chey, WD., Eswaran, S.[2018]

The low FODMAP diet is the most evidence-supported dietary intervention for treating irritable bowel syndrome (IBS), which affects 10% to 15% of the population.

While dietary therapies are becoming first-line treatments for IBS, healthcare providers must be cautious of the potential negative effects of restrictive diets and be vigilant for signs of maladaptive eating patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable Bowel Syndrome: Food as a Friend or Foe? Harer, KN., Eswaran, SL.[2021]

A low-FODMAP diet has been shown to significantly improve IBS symptoms in 52-86% of patients, making it a highly effective dietary intervention for this condition.

Patients who benefit from eliminating FODMAPs should follow a structured reintroduction process to identify specific food sensitivities, allowing for a personalized diet plan tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-FODMAP Diet for Irritable Bowel Syndrome: What We Know and What We Have Yet to Learn. Liu, J., Chey, WD., Haller, E., et al.[2020]

Citations

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The low-FODMAP dietary intervention led to significant improvement in IBS symptoms and encouraged healthier eating habits among adult participants.

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sciencedirect.com

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Low FODMAP Diet in IBD: Effects & Patient Experiences

A low FODMAP diet reduces symptoms of irritable bowel syndrome (IBS), but its impact on inflammatory bowel disease (IBD) is less established.

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Studies have shown that LFD can improve the QoL of patients with IBS by reducing GI symptoms [31]. Our analysis also confirms the maintenance of ...