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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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 mindfulness training and the low FODMAP diet safe for humans?

Mindfulness training and the low FODMAP diet have been studied for irritable bowel syndrome and other conditions, and they are generally considered safe for humans. Mindfulness training involves focusing on the present moment and being aware of body sensations and emotions, while the low FODMAP diet involves reducing certain carbohydrates to improve gut symptoms. ^{1 2 3 4 5}

How does the Low FODMAP Diet and Mindfulness Training treatment for IBS differ from other treatments?

The Low FODMAP Diet is unique because it focuses on reducing specific types of carbohydrates that can cause digestive issues, and it has shown significant effectiveness in improving IBS symptoms. Mindfulness Training, on the other hand, is a novel approach that addresses the psychological aspects of IBS by helping patients manage stress and anxiety, which can exacerbate symptoms, making this combination a holistic treatment option. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Mindfulness-based Attention Training for Irritable Bowel Syndrome?

Research shows that mindfulness training can significantly reduce IBS symptoms by helping patients become less reactive to anxiety and negative thoughts about their gut sensations, improving their quality of life. ^{1 2 4 10 11}

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic mechanisms of a mindfulness-based treatment for IBS: effects on visceral sensitivity, catastrophizing, and affective processing of pain sensations. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial. [2021]

3. Iran pubmed.ncbi.nlm.nih.gov

Long Term Effects of Mindfulness on Quality of life in Irritable Bowel Syndrome. [2020]

4. India pubmed.ncbi.nlm.nih.gov

Comparing the effect of internet-delivered short-term progressive muscle relaxation and psychoeducation on mindful ability, visceral hypersensitivity and symptoms of patients with irritable bowel syndrome. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapies in the treatment of functional gastrointestinal disorders: a meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Group education on the low FODMAP diet improves gastrointestinal symptoms but neither anxiety or depression in irritable bowel syndrome. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Irritable Bowel Syndrome: Food as a Friend or Foe? [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Low-FODMAP Diet for Irritable Bowel Syndrome: What We Know and What We Have Yet to Learn. [2020]

10. Australia pubmed.ncbi.nlm.nih.gov

The evidence base for efficacy of the low FODMAP diet in irritable bowel syndrome: is it ready for prime time as a first-line therapy? [2022]

11. England pubmed.ncbi.nlm.nih.gov

The role of diet in the management of irritable bowel syndrome: a focus on FODMAPs. [2018]