Mirtazapine + Low-FODMAP Diet for IBS

Recruiting in Palo Alto (17 mi)

Overseen by Brian E Lacy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Celiac disease, IBD, Anxiety, others

Trial Summary

What is the purpose of this trial?

The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people. You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Mirtazapine + Low-FODMAP Diet for IBS?

Research shows that a low-FODMAP diet can significantly improve IBS symptoms for 52-86% of patients by reducing certain carbohydrates that cause digestive issues. This suggests that combining this diet with other treatments like Mirtazapine could be beneficial for managing IBS. ^{1 2 3 4 5}

Is the combination of Mirtazapine and a low-FODMAP diet safe for humans?

The low-FODMAP diet is generally considered safe, but there are concerns about its long-term effects on nutrition and gut bacteria. There is no specific safety data available for the combination of Mirtazapine and a low-FODMAP diet. ^{4 5 6 7 8}

How does the treatment Mirtazapine + Low-FODMAP Diet for IBS differ from other treatments?

This treatment is unique because it combines Mirtazapine, a drug typically used for depression and anxiety, with a low-FODMAP diet, which is a dietary approach to reduce certain carbohydrates that can trigger IBS symptoms. This combination targets both the psychological and dietary aspects of IBS, potentially offering a more comprehensive approach than treatments focusing on just one aspect. ^{1 7 9 10 11}

Research Team

Brian E Lacy, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Adults aged 18-70 with diarrhea-predominant irritable bowel syndrome (IBS-D) who meet specific IBS criteria and have a significant symptom score can join. They must understand the study, follow its procedures, and not be pregnant if capable of reproduction.

Inclusion Criteria

Participants must have a score of greater than 175 on the IBS-SSS questionnaire

I am between 18 and 70 years old.

I can understand and follow the study's procedures.

Exclusion Criteria

Participants with a score of less than 175 on the IBS-SSS

I have been diagnosed with celiac, IBD, SIBO, or microscopic colitis.

Participants with a history of a known side effect to mirtazapine

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mirtazapine or placebo in combination with a low-FODMAP diet

7 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mirtazapine (Neuromodulator)

Trial Overview The trial is testing whether adding mirtazapine to a low-FODMAP diet provides more relief for IBS symptoms than the diet alone. Participants will either receive mirtazapine or a placebo while following the dietary restrictions.

Participant Groups

Group I: Mirtazapine Group Experimental Treatment 1 Intervention

Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving mirtazapine by pill form.

Group II: Placebo Group Placebo Group 1 Intervention

Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving placebo by pill form.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Findings from Research

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]

The low FODMAP diet has been shown to improve symptoms of irritable bowel syndrome (IBS) by reducing the intake of short-chain fermentable carbohydrates that can trigger gastrointestinal discomfort.

While there is growing clinical evidence supporting the effectiveness of the low FODMAP diet for IBS, it is important to consider potential drawbacks and to implement the diet carefully under professional guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition in the management of gastrointestinal diseases and disorders: the evidence for the low FODMAP diet. Eswaran, S., Farida, JP., Green, J., et al.[2018]

A low FODMAP diet significantly reduces abdominal pain in children with irritable bowel syndrome (IBS), with participants experiencing fewer pain episodes compared to a typical American childhood diet, as shown in a study involving 33 children.

The study suggests that certain gut microbiome characteristics, particularly those related to carbohydrate metabolism, may predict which children will respond positively to the low FODMAP diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Chumpitazi, BP., Cope, JL., Hollister, EB., et al.[2022]

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]

In a study of 459 primary care patients with IBS, a smartphone application promoting a low FODMAP diet resulted in a significantly higher symptom improvement rate (71%) compared to the spasmolytic agent otilonium bromide (61%) after 8 weeks.

The FODMAP diet not only showed better efficacy but also higher adherence rates (94% for diet vs. 73% for OB), suggesting it could be a more effective first-line treatment for IBS in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute. Carbone, F., Van den Houte, K., Besard, L., et al.[2023]

In a study of 233 IBS patients, 41% adhered to a low-FODMAP diet, and higher adherence was linked to a greater risk of eating disorder (ED) behaviors, with 23% of participants identified as at risk for EDs.

Patients with IBS who adhered to the low-FODMAP diet showed a significant difference in adherence rates between those at risk for EDs (57%) and those not at risk (35%), highlighting the need for clinicians to monitor for EDs in patients with high adherence to this restrictive diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence with a low-FODMAP diet in irritable bowel syndrome: are eating disorders the missing link? Mari, A., Hosadurg, D., Martin, L., et al.[2019]

A systematic review of nine randomized controlled trials involving 542 patients found that the low FODMAP diet for irritable bowel syndrome (IBS) has a high risk of bias, particularly in blinding, with only one trial being double-blinded.

The studies generally lasted from 2 days to 6 weeks, and there is a lack of research on the long-term effects and the important reintroduction phase of the diet, raising concerns that reported symptom improvements may be largely due to placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: quality of trials on the symptomatic effects of the low FODMAP diet for irritable bowel syndrome. Krogsgaard, LR., Lyngesen, M., Bytzer, P.[2022]

The low-FODMAP diet can help alleviate symptoms of irritable bowel syndrome (IBS), such as bloating and diarrhea, but the evidence supporting its effectiveness is limited due to methodological flaws in studies, including a lack of proper control groups.

Prolonged use of the low-FODMAP diet may lead to nutritional deficiencies because it restricts many staple foods, potentially resulting in lower intake of essential nutrients like fiber, calcium, and vitamins, especially for those with limited access to alternative foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Low FODMAP Diet: Many Question Marks for a Catchy Acronym. Catassi, G., Lionetti, E., Gatti, S., et al.[2022]

References

1. 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]

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

Nutrition in the management of gastrointestinal diseases and disorders: the evidence for the low FODMAP diet. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Low FODMAP in 2017: Lessons learned from clinical trials and mechanistic studies. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute. [2023]

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

Long-term personalized low FODMAP diet improves symptoms and maintains luminal Bifidobacteria abundance in irritable bowel syndrome. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adherence with a low-FODMAP diet in irritable bowel syndrome: are eating disorders the missing link? [2019]

9. England pubmed.ncbi.nlm.nih.gov

Systematic review: quality of trials on the symptomatic effects of the low FODMAP diet for irritable bowel syndrome. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Low FODMAP Diet: Many Question Marks for a Catchy Acronym. [2022]

11. India pubmed.ncbi.nlm.nih.gov

The low FODMAP diet improves gastrointestinal symptoms in patients with irritable bowel syndrome: a prospective study. [2022]