Dietary Interventions for Inflammatory Bowel Disease

(AID-IBD Trial)

Overseen By Vanina Noejovich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Pregnancy, Eating disorders, Schizophrenia, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, we are trying to learn how certain diets affect people with inflammatory bowel disease (IBD). We want to understand what makes it hard or easy for them to stick to different eating plans, like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet. By finding out how these diets help with symptoms and which ones are easier to follow, we hope to improve the quality of life for people with IBD.

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 focuses on dietary changes for people with inflammatory bowel disease.

What data supports the effectiveness of the treatment Intermittent Fasting Intervention, Low FODMAP Diet Intervention, Mediterranean Diet Intervention for Inflammatory Bowel Disease?

Research suggests that exclusion diets, including the Low FODMAP diet, show promise in improving symptoms for patients with inflammatory bowel disease (IBD). Additionally, specific dietary interventions like the Mediterranean diet have been shown to reduce symptoms and improve quality of life, although they are not a replacement for standard therapies. ^{1 2 3 4 5}

Is the low FODMAP diet safe for humans?

The low FODMAP diet can help manage symptoms of inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), but it involves restricting certain foods, which might lead to nutritional deficiencies and affect gut bacteria balance. ^{6 7 8 9 10}

How does the dietary treatment for Inflammatory Bowel Disease differ from other treatments?

This dietary treatment for Inflammatory Bowel Disease (IBD) is unique because it focuses on specific eating patterns like intermittent fasting, the low FODMAP diet, and the Mediterranean diet, which aim to reduce inflammation and improve symptoms. Unlike standard drug therapies, these diets may help manage IBD by altering food intake to support gut health and immune function, though they are typically used alongside traditional treatments rather than as replacements. ^{1 5 6 11 12}

Eligibility Criteria

This trial is for individuals with IBD, including Ulcerative Colitis and Crohn's Disease. Participants should be interested in testing how different diets may impact their condition.

Inclusion Criteria

I am willing to use my smartphone for the trial app.

I am over 18 and have been diagnosed with ulcerative colitis or Crohn's disease.

Able to understand the indication by the registered dietitian

Exclusion Criteria

I have diabetes.

I have advanced chronic kidney disease.

I have short bowel syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow assigned dietary interventions: intermittent fasting, Mediterranean diet, or Low FODMAP diet

8-12 weeks

Follow-up

Participants are monitored for adherence and perceived benefits of dietary interventions

4 weeks

Treatment Details

Interventions

• Intermittent Fasting Intervention
• Low FODMAP Diet Intervention
• Mediterranean Diet Intervention

Trial Overview The study examines the effects of three diet interventions on IBD symptoms: intermittent fasting, Mediterranean diet, and Low FODMAP diet. It also assesses participants' adherence to these eating plans.

Participant Groups

Group I: Mediterranean Diet Experimental Treatment 1 Intervention

Participants will be assigned to follow a Mediterranean diet.

Group II: Low FODMAP Diet Experimental Treatment 1 Intervention

Participants will be assigned to follow a Low FODMAP Diet.

Group III: Intermittent Fasting Experimental Treatment 1 Intervention

Participants will be assigned to follow an intermittent fasting protocol.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Findings from Research

A systematic review of clinical trials found that dietary interventions, particularly exclusion diets and low FODMAP diets, may significantly improve symptoms in patients with inflammatory bowel disease (IBD).

Higher quality studies indicated that these specific dietary approaches were more effective than control diets, suggesting that diet can be an important part of the treatment plan for IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Dietary Interventions on the Symptoms of Inflammatory Bowel Disease: A Systematic Review. Charlebois, A., Rosenfeld, G., Bressler, B.[2022]

Diet plays a significant role in the onset and severity of inflammatory bowel diseases (IBDs), as it can influence immune system regulation and intestinal health.

While enteral nutrition is effective for treating pediatric Crohn's disease, there is a lack of research on the impact of whole food dietary interventions, highlighting the need for further studies to explore dietary patterns and their potential in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet in Treatment of Inflammatory Bowel Diseases. Sasson, AN., Ananthakrishnan, AN., Raman, M.[2022]

In a study of 1254 IBD patients, only a small percentage (4.1% for vegetarian diets and 4.7% for gluten-free diets) reported following restrictive diets, and these diets did not significantly affect disease activity or hospitalization rates.

However, patients on vegetarian or gluten-free diets experienced higher levels of anxiety, depression, and post-traumatic stress symptoms, indicating a potential negative impact on psychological well-being despite no direct effect on their IBD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vegetarian or gluten-free diets in patients with inflammatory bowel disease are associated with lower psychological well-being and a different gut microbiota, but no beneficial effects on the course of the disease. Schreiner, P., Yilmaz, B., Rossel, JB., et al.[2020]

The review highlights various dietary approaches, including exclusive enteral nutrition (EEN), the Specific Carbohydrate Diet (SCD), and the low FODMAP diet, which may influence inflammation in inflammatory bowel disease (IBD).

While no specific macronutrient has been consistently linked to the development of IBD, exclusion diets show promise in managing symptoms, though the existing data has both strengths and limitations that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet as a Therapeutic Option for Adult Inflammatory Bowel Disease. Kakodkar, S., Mutlu, EA.[2018]

In a study of 100 children and adolescents with mild to moderate inflammatory bowel disease (IBD), those who adhered to the Mediterranean diet (MD) for 12 weeks showed significant improvements in disease activity and inflammatory markers compared to those on their usual diet.

Patients following the MD experienced earlier and greater reductions in clinical scores and inflammatory markers, indicating that the MD may be a beneficial dietary intervention for managing IBD in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean Diet Improved Clinical Scores and Inflammatory Markers in Children with Active Inflammatory Bowel Disease: A Randomized Trial. El Amrousy, D., Elashry, H., Salamah, A., et al.[2022]

A low FODMAP diet significantly improves gastrointestinal symptoms in patients with inflammatory bowel disease (IBD), including reductions in diarrhea, abdominal pain, bloating, fatigue, and nausea, based on a meta-analysis of 319 patients.

The analysis indicates that while the diet is effective for most symptoms, it did not show a significant impact on constipation, highlighting the need for further research to confirm these findings and explore long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is a low FODMAP diet beneficial for patients with inflammatory bowel disease? A meta-analysis and systematic review. Zhan, YL., Zhan, YA., Dai, SX.[2019]

In a study of 205 IBS patients followed for an average of 44 months, 60% reported adequate symptom relief while adhering to a personalized low FODMAP diet (pLFD).

Most participants (80%) continued to consume 'free-from' products, particularly gluten or wheat-free items, indicating a long-term commitment to dietary changes for managing their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The low FODMAP diet for IBS; A multicentre UK study assessing long term follow up. Rej, A., Shaw, CC., Buckle, RL., et al.[2022]

Current evidence on the impact of diet on adult inflammatory bowel disease (IBD) is limited, with many studies being small and not well-controlled, highlighting the need for larger, more rigorous clinical trials.

Diets such as Mediterranean, vegetarian/vegan, and reduced-calorie/fasting have shown promise in related immune-mediated inflammatory diseases and may be beneficial for IBD, while gluten-free and low FODMAP diets do not significantly affect IBD activity but may help with related gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. Jiang, Y., Jarr, K., Layton, C., et al.[2022]

References

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

The Impact of Dietary Interventions on the Symptoms of Inflammatory Bowel Disease: A Systematic Review. [2022]

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

Diet in Treatment of Inflammatory Bowel Diseases. [2022]

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

Vegetarian or gluten-free diets in patients with inflammatory bowel disease are associated with lower psychological well-being and a different gut microbiota, but no beneficial effects on the course of the disease. [2020]

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

Nutrition and diet in inflammatory bowel disease. [2023]

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

Dietary Exposures and Interventions in Inflammatory Bowel Disease: Current Evidence and Emerging Concepts. [2023]

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

Diet as a Therapeutic Option for Adult Inflammatory Bowel Disease. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean Diet Improved Clinical Scores and Inflammatory Markers in Children with Active Inflammatory Bowel Disease: A Randomized Trial. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

FODMAPs, inflammatory bowel disease and gut microbiota: updated overview on the current evidence. [2022]

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

Is a low FODMAP diet beneficial for patients with inflammatory bowel disease? A meta-analysis and systematic review. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The low FODMAP diet for IBS; A multicentre UK study assessing long term follow up. [2022]

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

Nutrition support in inflammatory bowel disease. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. [2022]