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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well people with inflammatory bowel disease (IBD) can handle different personalized diets high in fiber. The study compares two types of diets: one high in pectin, found in fruits like apples, and another high in B-fructan, a type of fiber found in foods like onions. It aims to determine which diet best suits individuals based on their personal response to these fibers. Participants should have known or suspected IBD, be stable on their current treatment, and be willing to collect samples and data. As an unphased trial, this study offers a unique opportunity to contribute to personalized dietary strategies for IBD management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that although limited safety information exists, personalized diets like the B-fructan diet could help treat inflammatory bowel disease (IBD). Some studies found that while many patients tolerate these diets well, undigested B-fructan fibers can cause inflammation in some individuals. This suggests the diet might not suit everyone with IBD. However, most participants in these studies found the diet easy to follow, with few side effects. It's important to note that individual reactions vary, so monitoring and adjusting the diet as needed is often necessary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for inflammatory bowel disease (IBD), which often rely on medications like corticosteroids and immunosuppressants, the personalized B-fructan diet offers a nutritional approach tailored to individual patients. Researchers are excited about this treatment because it uses B-fructans, which are prebiotics that can potentially modulate gut microbiota in a beneficial way, aiming to reduce inflammation naturally. This personalized dietary strategy is unique as it considers the specific needs and gut profiles of patients, potentially leading to more effective and sustainable management of IBD symptoms without the side effects associated with long-term medication use.

What evidence suggests that this trial's personalized dietary treatments could be effective for inflammatory bowel disease?

Research has shown that personalized diets might help manage inflammatory bowel disease (IBD). In this trial, participants will follow different diet plans. One such diet, the personalized B-fructan diet, has shown promising early results, though human studies remain limited. This diet focuses on certain fibers that may reduce gut inflammation. Similarly, the personalized pectin diet, also under study in this trial, has shown potential for reducing inflammation by controlling immune responses, as seen in studies using colitis models, which help researchers understand IBD. Both diets are being studied for their ability to lower inflammation and improve gut health in people with IBD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05615779

Personalized B-fructan Diet in Inflammatory Bowel Disease ... Study Overview. This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B- ...

2. withpower.com withpower.com/trial/phase-ulcerative-colitis-10-2022-f85f2

Personalized Diet for 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725003092

From traditional to artificial intelligence-driven approaches ... This review aims to summarize accumulating data on the effects of dietary interventions in IBD patients and introduce the role of artificial intelligence (AI)

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10782214/

Diet and Nutrition in Inflammatory Bowel Disease Diet is thought to contribute to the development of inflammatory bowel disease (IBD) and may act as a mediator of inflammation in patients with IBD.

5. mdpi.com mdpi.com/2072-6643/15/3/579

Dietary Exposures and Interventions in Inflammatory Bowel ... In this review, we provide a contemporary and comprehensive overview of dietary exposures and interventions in IBD.

6. clinconnect.io clinconnect.io/trials/NCT05615779

Personalized B-fructan Diet in Inflammatory Bowel - ClinConnect This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based ...

7. gastrojournal.org gastrojournal.org/article/S0016-5085(22)01150-7/fulltext

Unfermented β-fructan Fibers Fuel Inflammation in Select ... Here we demonstrate that unfermented dietary β-fructans induce proinflammatory cytokine secretion in select patients with IBD, mediated by ...