Fermented Foods Diet for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Overseen by Sidhartha Sinha, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Pregnancy, Low BMI, Severe cardiac, others

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It mentions that appropriate medical treatment for Ulcerative Colitis and related conditions will not be withheld, so you may be able to continue your current medications.

What data supports the effectiveness of the treatment Fermented Food-supplemented Diet for Ulcerative Colitis?

Research shows that fermented foods containing probiotics like Bifidobacterium breve and Lactobacillus strains can help improve symptoms in ulcerative colitis by supporting gut health and reducing inflammation. ^{1 2 3 4 5}

Are fermented foods generally safe for human consumption?

Fermented foods have been consumed safely by humans for thousands of years and are generally considered safe, with some evidence suggesting they may offer health benefits beyond basic nutrition. ^{3 6 7 8 9}

How is the Fermented Foods Diet treatment for ulcerative colitis different from other treatments?

The Fermented Foods Diet for ulcerative colitis is unique because it focuses on using fermented foods, which contain probiotics (beneficial bacteria) and bioactive molecules, to improve gut health and reduce inflammation. This approach is different from standard treatments as it aims to enhance the intestinal barrier and balance gut microbiota, potentially offering a natural and dietary-based alternative to traditional medications. ^{1 4 10 11 12}

Research Team

Sidhartha Sinha, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for men and women over 18 with mild to moderate Ulcerative Colitis (UC), confirmed by diagnosis. Participants must have symptoms, shown by a partial Mayo Score of 2-7, and elevated fecal calprotectin levels. They need to give written consent to join.

Inclusion Criteria

Written informed consent

I am 18 years old or older.

Elevated fecal calprotectin

Exclusion Criteria

Intolerance to fermented food

I am currently pregnant, nursing, or planning to become pregnant.

Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental arm supplement their diet with fermented foods over 10 weeks, while the control arm maintains a regular diet with limited fermented food intake.

10 weeks

Follow-up

Participants are monitored for changes in inflammatory markers, quality of life, and gut microbiome profiles after the treatment phase.

4 weeks

Treatment Details

Interventions

• Fermented Food-supplemented Diet (Behavioural Intervention)
• Regular Diet (Behavioural Intervention)

Trial Overview The study aims to understand the impact of a diet supplemented with fermented foods on inflammation and life quality in UC patients compared to those on a regular diet. It explores how these foods might affect gut health and inflammatory responses.

Participant Groups

Group I: Fermented Food-Supplemented Diet Experimental Treatment 1 Intervention

Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks.

Group II: Regular Diet Control Arm Placebo Group 1 Intervention

Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

In a study involving 41 patients with mild to moderate ulcerative colitis (UC), treatment with the synbiotics Bifidobacterium breve strain Yakult and galacto-oligosaccharide (GOS) for one year led to significant clinical improvements as assessed by colonoscopy.

The synbiotics not only improved the clinical status of UC patients but also reduced inflammation markers and altered gut bacteria composition, suggesting a beneficial effect on disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of probiotic bifidobacterium and galacto-oligosaccharide in patients with ulcerative colitis: a randomized controlled study. Ishikawa, H., Matsumoto, S., Ohashi, Y., et al.[2011]

The study found that TK1501 fermented soybeans can alleviate colitis in mice, and this effect is primarily due to bacterial metabolites rather than the presence of live or dead bacteria.

Key metabolites, specifically lipoteichoic acid and peptidoglycan, were identified as the main active ingredients, with lipoteichoic acid enhancing macrophage phagocytosis and peptidoglycan potentially increasing mucin-2 expression, suggesting a mechanism for the anti-inflammatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus paracasei TK1501 fermented soybeans alleviate dextran sulfate sodium-induced colitis by regulating intestinal cell function. Chen, K., Luo, H., Li, Y., et al.[2023]

Whey fermented with the probiotic Lactobacillus rhamnosus significantly improved gastrointestinal health in a mouse model of ulcerative colitis, reducing disease activity and enhancing blood and tissue health indicators.

The consumption of this fermented whey led to lower levels of pro-inflammatory markers and higher levels of anti-inflammatory cytokines, suggesting it helps maintain intestinal barrier integrity and immune balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of potential probiotic Lactobacillus rhamnosus (MTCC-5897) fermented whey on reinforcement of intestinal epithelial barrier function in a colitis-induced murine model. Kaur, H., Gupta, T., Kapila, S., et al.[2022]

Bifidobacterium strains-fermented milk has shown potential as a beneficial adjunct in preventing the recurrence or worsening of colitis, based on both animal studies and human clinical trials involving ulcerative colitis patients.

The review highlights the effectiveness of probiotic foods not only for healthy individuals but also for those suffering from digestive diseases, suggesting a broader application of probiotics in gastrointestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for Using of Bifidobacterium Probiotic Strains-Fermented Milk Against Colitis Based on Animal Experiments and Clinical Trials. Imaoka, A., Umesaki, Y.[2018]

Fermented foods, like yogurt and kimchi, not only improve shelf life and safety but also enhance nutritional value and functional properties due to the transformation of their ingredients during fermentation.

Emerging evidence suggests that fermented foods may offer health benefits beyond their original ingredients, potentially due to the presence of live microorganisms similar to probiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of fermented foods: microbiota and beyond. Marco, ML., Heeney, D., Binda, S., et al.[2018]

Fermented foods have been part of human diets for thousands of years and are now recognized for their beneficial microbial properties that support gastrointestinal health and potentially other bodily functions.

Despite their health benefits, fermented foods are not widely recommended in global food guides, highlighting a need for health authorities to advocate for their inclusion in dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of fermented foods in food guides around the world. Chilton, SN., Burton, JP., Reid, G.[2018]

Lactic acid fermentation, especially when combined with germinated cereals, can enhance the nutritional quality and safety of weaning foods by providing high nutrient density and antimicrobial properties.

The workshop identified key research priorities, including understanding the effects of fermentation on harmful microorganisms and mycotoxins, optimizing fermentation processes, and improving food safety practices for better consumer acceptance of fermented foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food fermentation: a safety and nutritional assessment. Joint FAO/WHO Workshop on Assessment of Fermentation as a Household Technology for Improving Food Safety. Motarjemi, Y., Nout, MJ.[2022]

In a study using a dextran sodium sulfate mouse model of ulcerative colitis, fermented rice extracts (FRe) significantly improved symptoms such as weight loss and inflammation when administered at 300 mg/kg, indicating its potential as a therapeutic option for UC.

FRe not only reduced proinflammatory cytokines and neutrophil infiltration but also enhanced intestinal barrier integrity and increased beneficial gut bacteria, suggesting a multifaceted mechanism of action that supports gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of fermented rice extract on ulcerative colitis induced by dextran sodium sulfate in mice. Oh, WS., Jung, JC., Choi, YM., et al.[2023]

In a 6-month study with 53 adult patients with ulcerative colitis in remission, those following an Anti-inflammatory Diet (AID) had a significantly lower rate of clinical relapse (19.2%) compared to those on Canada's Food Guide (29.6%).

The AID group showed a higher subclinical response, with 69.2% maintaining low fecal calprotectin levels, indicating less inflammation, and experienced beneficial changes in gut microbiota and metabolites, suggesting that dietary modifications can effectively support remission in UC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Inflammatory Diet Prevents Subclinical Colonic Inflammation and Alters Metabolomic Profile of Ulcerative Colitis Patients in Clinical Remission. Keshteli, AH., Valcheva, R., Nickurak, C., et al.[2023]

In a study of 74 patients with mild-to-moderate ulcerative colitis, Profermin significantly reduced the Simple Clinical Colitis Activity Index (SCCAI) score compared to Fresubin after 8 weeks, indicating its efficacy in managing flare-ups.

Profermin was associated with a higher remission rate (31% vs. 15%) and a greater percentage of patients achieving a ≥50% decrease in SCCAI scores, while also demonstrating a lower dropout rate due to treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profermin is efficacious in patients with active ulcerative colitis--a randomized controlled trial. Krag, A., Munkholm, P., Israelsen, H., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial effects of probiotic bifidobacterium and galacto-oligosaccharide in patients with ulcerative colitis: a randomized controlled study. [2011]

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

Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis. [2018]

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

Lactobacillus paracasei TK1501 fermented soybeans alleviate dextran sulfate sodium-induced colitis by regulating intestinal cell function. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Protective effects of potential probiotic Lactobacillus rhamnosus (MTCC-5897) fermented whey on reinforcement of intestinal epithelial barrier function in a colitis-induced murine model. [2022]

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

Rationale for Using of Bifidobacterium Probiotic Strains-Fermented Milk Against Colitis Based on Animal Experiments and Clinical Trials. [2018]

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

Health benefits of fermented foods: microbiota and beyond. [2018]

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

Inclusion of fermented foods in food guides around the world. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Fermented Foods: Definitions and Characteristics, Impact on the Gut Microbiota and Effects on Gastrointestinal Health and Disease. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Food fermentation: a safety and nutritional assessment. Joint FAO/WHO Workshop on Assessment of Fermentation as a Household Technology for Improving Food Safety. [2022]

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

Protective effects of fermented rice extract on ulcerative colitis induced by dextran sodium sulfate in mice. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Inflammatory Diet Prevents Subclinical Colonic Inflammation and Alters Metabolomic Profile of Ulcerative Colitis Patients in Clinical Remission. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Profermin is efficacious in patients with active ulcerative colitis--a randomized controlled trial. [2018]