Personalized Diet for Inflammatory Bowel Disease

Recruiting at 1 trial location

Overseen By Eytan Wine, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Antibiotics, Probiotics, Steroids

Disqualifiers: Abdominal surgery, Enteric infection, Systemic disease, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.

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

The trial requires that your current IBD treatment be stable, meaning no changes in biologics or immunomodulators in the last month. You cannot be on systemic steroids above 10 mg/day of Prednisone or have had a recent change in IBD treatment. If your treatment is stable, you likely won't need to stop your current medications.

What data supports the idea that Personalized Diet for Inflammatory Bowel Disease is an effective treatment?

The available research shows that there is not enough strong evidence to make firm dietary recommendations for treating Inflammatory Bowel Disease (IBD) with a personalized diet. While some studies mention that patients often report certain foods affecting their symptoms, there is no clear data supporting the effectiveness of a Personalized Diet for IBD. Other diets, like the low FODMAP diet, are more commonly discussed and have some evidence suggesting they might help manage symptoms. However, the overall lack of rigorous scientific evidence makes it difficult to conclude that a Personalized Diet is an effective treatment for IBD. ^{1 2 3 4 5}

What safety data exists for personalized diets in treating inflammatory bowel disease?

The safety data for personalized diets, such as those involving beta2-1 fructans, in treating inflammatory bowel disease (IBD) is limited but promising. Studies suggest that beta2-1 fructans, which are prebiotic fibers, can modulate immune function and reduce intestinal inflammation. Animal studies have shown benefits in immune response and inflammation, while human studies have reported some positive effects on IBD. However, many studies are small and not well-controlled, indicating a need for more rigorous research to confirm these findings. ^{1 2 5 6 7}

Is the Personalized B-fructan diet a promising treatment for Inflammatory Bowel Disease?

The Personalized B-fructan diet could be promising for treating Inflammatory Bowel Disease because diet plays an important role in managing the condition. While there isn't strong scientific evidence yet, many patients believe specific diets help their symptoms, and ongoing research is exploring these possibilities. ^{4 5 7 8 9}

Eligibility Criteria

This trial is for children (6-17) and young adults (18-39) with Ulcerative Colitis or IBD, who are not in severe condition (Mayo score <10). They should be undergoing a colonoscopy but not on steroids, and their treatment hasn't changed recently. Non-IBD individuals and healthy family members can also participate as controls.

Inclusion Criteria

My current treatment hasn't changed in the last month and I'm not on steroids.

My condition affects the middle to lower parts of my body.

I either have or am suspected to have ulcerative colitis or indeterminate colitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized dietary fibre recommendations (high-pectin diet versus high-B-fructan diet) based on personalized responses

12 weeks

4 visits (in-person) at weeks 1, 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalized B-fructan diet

Trial Overview The study tests if personalized diets high in either pectin or B-fructan fibers, recommended by an IBD dietician based on individual responses, can be tolerated well by patients with Inflammatory Bowel Disease.

Participant Groups

Group I: Personalized pectin diet Experimental Treatment 1 Intervention

Group II: Personalized B-fructan diet Experimental Treatment 1 Intervention

Group III: Randomized pectin diet Placebo Group 1 Intervention

Group IV: Randomized B-fructan diet Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Findings from Research

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]

A low-fiber diet may increase the risk of inflammatory bowel disease (IBD) by contributing to intestinal dysbiosis and chronic inflammation.

Certain dietary fiber components, like β-glucan and inulin, can help prevent IBD by positively influencing gut microbiota composition and strengthening the intestinal barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components of the Fiber Diet in the Prevention and Treatment of IBD-An Update. Ferenc, K., Jarmakiewicz-Czaja, S., Filip, R.[2023]

Patients with active inflammatory bowel disease (IBD) showed significantly lower intakes of essential micronutrients like iron, folate, and vitamin C compared to healthy controls, indicating potential nutritional deficiencies.

All IBD groups, including those with inactive IBD experiencing gut symptoms, consumed less total fiber and FODMAPs than controls, which correlated with a poorer food-related quality of life (FR-QoL), suggesting that dietary restrictions may negatively impact their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient, Fibre, and FODMAP Intakes and Food-related Quality of Life in Patients with Inflammatory Bowel Disease, and Their Relationship with Gastrointestinal Symptoms of Differing Aetiologies. Cox, SR., Clarke, H., O'Keeffe, M., et al.[2022]

Patients with inflammatory bowel disease (IBD) reported that certain foods, like yogurt, rice, and bananas, can improve their symptoms, while others, such as spicy foods, fried foods, and high-fiber items, are believed to worsen symptoms.

Patients with ostomies tended to consume more dairy and processed foods compared to those without ostomies, suggesting that dietary patterns may vary significantly among different IBD patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and self-reported associations of diet with symptoms of inflammatory bowel disease. Cohen, AB., Lee, D., Long, MD., et al.[2021]

Patients with inflammatory bowel disease (IBD) are increasingly seeking nonpharmacologic dietary approaches to manage their condition, highlighting the importance of diet in IBD treatment.

While several diets, including the low-FODMAP diet, specific carbohydrate diet, anti-inflammatory diet, and Paleolithic diet, are popular among IBD patients, there is currently a lack of rigorous scientific evidence to definitively recommend one diet over another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Inflammatory Bowel Disease. Knight-Sepulveda, K., Kais, S., Santaolalla, R., et al.[2020]

Beta2-1 fructans can enhance immune function and help the body combat intestinal infections, as shown by 21 studies in laboratory animals and multiple human studies involving children and adults.

While beta2-1 fructans show promise in improving outcomes for certain inflammatory conditions like inflammatory bowel disease, their effects on adults are less consistent, indicating that their benefits may vary based on specific situations and populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics, immune function, infection and inflammation: a review of the evidence. Lomax, AR., Calder, PC.[2009]

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]

Current understanding suggests that inflammatory bowel disease (IBD) arises from a complex interplay of genetic, immunologic, and environmental factors, including diet and microbes.

Despite some studies indicating dietary factors like high refined sugar intake and fast food consumption in IBD patients, there is no consistent evidence of pre-existing nutritional abnormalities that reliably predict the development of IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition in the etiopathogenesis of chronic inflammatory bowel diseases]. Weinand, I., Jordan, A., Caspary, WF., et al.[2016]

In a study of 40 patients with inflammatory bowel disease (IBD), 60% of those who followed the Anti-Inflammatory Diet (IBD-AID) reported good or very good responses, with all patients experiencing symptom reduction and the ability to discontinue at least one medication.

Among 11 patients reviewed in detail, significant improvements were observed in disease severity scores, with the Harvey Bradshaw Index decreasing from a mean of 11 to 1.5 and the Modified Truelove and Witts Severity Index dropping from 7 to 0 after following the diet for at least 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Olendzki, BC., Silverstein, TD., Persuitte, GM., et al.[2022]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Components of the Fiber Diet in the Prevention and Treatment of IBD-An Update. [2023]

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

Nutrient, Fibre, and FODMAP Intakes and Food-related Quality of Life in Patients with Inflammatory Bowel Disease, and Their Relationship with Gastrointestinal Symptoms of Differing Aetiologies. [2022]

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

Dietary patterns and self-reported associations of diet with symptoms of inflammatory bowel disease. [2021]

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

Diet and Inflammatory Bowel Disease. [2020]

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

Prebiotics, immune function, infection and inflammation: a review of the evidence. [2009]

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

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

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

[Nutrition in the etiopathogenesis of chronic inflammatory bowel diseases]. [2016]

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

An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. [2022]