LEAP Program for Irritable Bowel Syndrome

Overseen By Michael A McLean, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oxford Biomedical Technologies, Inc.

Disqualifiers: Inflammatory bowel, Celiac, Cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of your current medications for at least one month before joining. It does not specify that you need to stop taking them.

What data supports the effectiveness of the LEAP Program treatment for Irritable Bowel Syndrome?

Research shows that personalized dietary changes, like those in the LEAP Program, can significantly reduce IBS symptoms and improve quality of life. A study found that participants experienced a notable decrease in gastrointestinal symptoms and better overall well-being after following the program. ^{1 2 3 4 5}

Is the LEAP Program safe for humans?

The available research does not provide specific safety data for the LEAP Program or its variations, but it suggests that dietary interventions, like elimination diets, are generally safe for most people with irritable bowel syndrome, except for those with certain eating disorders. ^{2 4 5 6 7}

How is the LEAP Program treatment different from other treatments for IBS?

The LEAP Program is unique because it uses a personalized dietary approach based on the Leukocyte Activation Assay-MRT (a test that measures immune cell reactions to foods) to improve IBS symptoms, unlike standard elimination diets that broadly restrict certain foods without personalization. ^{2 4 5 6 8}

Research Team

Gustavo Zarini, Ph.D., RD

Principal Investigator

Oxford Biomedical Technologies, Inc.

Eligibility Criteria

This trial is for adults with moderate to severe IBS-D, diagnosed by Rome III or IV criteria. Participants must have been on a stable dose regimen for at least a month and be willing to follow the LEAP program for three months. They should not be pregnant, undergoing cancer treatment, have kidney failure, inflammatory bowel disease, celiac disease, or a BMI of 40+.

Inclusion Criteria

Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria

Must be on a stable dose regimen for at least 1 month prior to enrollment

Willing to follow the LEAP program for 3 months

Exclusion Criteria

Pregnancy or planned pregnancy or lactation

You have had cancer in the past and are currently receiving treatment for it.

You have had kidney failure in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a tailored anti-inflammatory eating plan guided by a registered dietitian as part of the LEAP program

12 weeks

6 visits (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lifestyle Eating and Performance (LEAP) Program

Trial Overview The study tests the effectiveness of an anti-inflammatory eating plan tailored to individual needs using LAA-MRT results. It's guided by dietitians over three months and aims to manage symptoms of irritable bowel syndrome (IBS).

Participant Groups

Group I: Participants Experimental Treatment 1 Intervention

Individuals with Irritable Bowel Syndrome (IBS)

Lifestyle Eating and Performance (LEAP) Program is already approved in United States for the following indications:

Approved in United States as LEAP Program for:

• Irritable Bowel Syndrome (IBS)

Who Is Running the Clinical Trial?

Oxford Biomedical Technologies, Inc.

Lead Sponsor

Trials

1

Recruited

60+

Findings from Research

A consensus document was created by a task force of multiple scientific societies to provide guidelines on exclusion diets for managing irritable bowel syndrome (IBS), a common digestive disorder.

The document aims to enhance dietary counseling for IBS patients, emphasizing the importance of diet and healthy habits alongside medication for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus document on exclusion diets in irritable bowel syndrome (IBS). Casellas, F., Burgos, R., Marcos, A., et al.[2019]

The LEAP program, guided by the Leukocyte Activation Assay-MRT, significantly improved IBS symptoms and quality of life in a retrospective study of 146 adults, with notable reductions in gastrointestinal symptoms (P < 0.001).

Participants, primarily female and followed for about 10 weeks, benefited from personalized dietary modifications, highlighting the importance of tailored dietary approaches in managing IBS effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Personalized Dietary Therapy Effective for Individuals With Irritable Bowel Syndrome? Zarini, GG., McLean, MA., Delgado, SI.[2023]

A low FODMAP diet was reported to be effective by 86% of patients with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), with significant improvements in symptoms like bloating (82%) and abdominal pain (71%).

Patients on the low FODMAP diet experienced a notable reduction in chronic disease courses and an increase in normal stool frequency, indicating that this dietary approach can lead to better management of bowel symptoms in both IBS and IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up of patients with functional bowel symptoms treated with a low FODMAP diet. Maagaard, L., Ankersen, DV., Végh, Z., et al.[2022]

Dietary interventions, particularly elimination diets, are commonly used to treat irritable bowel syndrome (IBS), but they may not be suitable for all patients, especially those with orthorexia nervosa or avoidant/restrictive food intake disorder.

Current dietary strategies should be personalized based on individual symptoms and biomarkers, as diet interventions are effective for only a subset of IBS patients, and there is growing interest in 'functional foods' as a complementary approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elimination Diets for Irritable Bowel Syndrome: Approaching the End of the Beginning. Chey, WD.[2019]

The 5Ad Dietary Protocol was tested on 22 subjects with functional bowel disorders (FBDs) and resulted in significant improvements in all abdominal symptoms, indicating its efficacy in reducing gastrointestinal issues.

Improvements in stool consistency and frequency were observed regardless of factors like BMI, age, or prior IBS diagnosis, suggesting that the 5Ad Dietary Protocol could be a versatile treatment option for various forms of FBDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 5Ad Dietary Protocol for Functional Bowel Disorders. Ibrahim, F., Stribling, P.[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]

A low FODMAP diet (LFD) was more effective than a standard diet in relieving symptoms of irritable bowel syndrome (IBS), particularly abdominal pain and diarrhea, in a study of 70 adults over four weeks.

Both diets improved quality of life, but the LFD group maintained symptom relief even after reintroducing FODMAPs, suggesting it may be a preferred dietary approach for individuals with IBS, especially those experiencing diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Two Dietary Approaches on the Quality of Life and Gastrointestinal Symptoms of Individuals with Irritable Bowel Syndrome. Guerreiro, MM., Santos, Z., Carolino, E., et al.[2020]

The low FODMAP diet has been shown to be effective in managing symptoms for a majority of patients with irritable bowel syndrome (IBS), based on recent studies.

While probiotics show promise in IBS treatment, their effectiveness varies by strain and dosage, indicating a need for further research to identify the most beneficial options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome and diet: where are we in 2018? Dimidi, E., Rossi, M., Whelan, K.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Consensus document on exclusion diets in irritable bowel syndrome (IBS). [2019]

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

Is Personalized Dietary Therapy Effective for Individuals With Irritable Bowel Syndrome? [2023]

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

Follow-up of patients with functional bowel symptoms treated with a low FODMAP diet. [2022]

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

Elimination Diets for Irritable Bowel Syndrome: Approaching the End of the Beginning. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A 5Ad Dietary Protocol for Functional Bowel Disorders. [2020]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Two Dietary Approaches on the Quality of Life and Gastrointestinal Symptoms of Individuals with Irritable Bowel Syndrome. [2020]

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

Irritable bowel syndrome and diet: where are we in 2018? [2022]