Prebiotics for Ulcerative Colitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Prior colectomy, Active malignancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD. Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.

Will I have to stop taking my current medications?

You can continue taking your current medications like 5-aminosalicylates, immunomodulators, corticosteroids, and biologic therapy, as long as you haven't started or changed the dose in the last 30 to 60 days. However, you will need to stop using probiotics or other dietary supplements during the trial.

What data supports the effectiveness of the treatment Prebiotic, Oligofructose-enriched inulin (OEI), Prebiotin for ulcerative colitis?

Research shows that inulin-type fructans, similar to oligofructose-enriched inulin, can reduce symptoms of ulcerative colitis by improving gut health and increasing beneficial short-chain fatty acids. This suggests that OEI may also help manage ulcerative colitis by promoting a healthier gut environment. ^{1 2 3 4 5}

Is the prebiotic oligofructose-enriched inulin (OEI) safe for humans?

Research on oligofructose-enriched inulin (OEI) for ulcerative colitis suggests it is generally safe, with studies showing it can improve gut health without significant side effects. However, more extensive studies are needed to confirm its safety across different conditions. ^{1 3 4 5 6}

How does the prebiotic treatment for ulcerative colitis differ from other treatments?

The prebiotic treatment using oligofructose-enriched inulin (OEI) is unique because it focuses on altering the gut microbiota to improve health, specifically by increasing beneficial bacteria like Bifidobacterium and Lactobacillus, and enhancing the production of short-chain fatty acids, which can help reduce inflammation and maintain remission in ulcerative colitis patients. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for individuals with Ulcerative Colitis or other forms of Inflammatory Bowel Disease. Participants should be interested in how diet affects their condition and willing to take prebiotic supplements. They'll need to provide stool samples and dietary information regularly.

Inclusion Criteria

I have been diagnosed with ulcerative colitis through a biopsy.

I am experiencing noticeable symptoms from my condition.

I am using certain medications without changes in the last 30 days.

Exclusion Criteria

Concerns for non-compliance

I have been hospitalized.

I need urgent surgery in my abdomen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Dietary composition is assessed at baseline

1 week

1 visit (in-person)

Treatment

Participants receive an 8-week course of prebiotic supplementation starting at either week 0 or week 8

8 weeks

2 visits (in-person) for stool sample collection at weeks 0 and 8

Follow-up

Participants are monitored for clinical remission and microbial composition changes

8 weeks

1 visit (in-person) at week 16

Treatment Details

Interventions

• Prebiotic

Trial Overview The study tests the effects of prebiotics on gut health over 16 weeks. Participants will start taking a prebiotic supplement either immediately or after an initial 8-week period, to see if it changes the gut microbiome and improves symptoms.

Participant Groups

Group I: Prebiotic at Week 0 Experimental Treatment 1 Intervention

Group II: Prebiotic at Week 8 Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

Xylo-oligosaccharide (XOS) has been shown to promote the growth of beneficial gut bacteria in patients with ulcerative colitis (UC) in clinical remission, suggesting it can help restore gut microbiota balance.

In a study involving five UC patients and five healthy volunteers, XOS fermentation increased the abundance of beneficial bacterial groups like Roseburia and Lactobacillus, indicating its potential as a prebiotic for maintaining remission in UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Xylo-Oligosaccharide on the Gut Microbiota of Patients With Ulcerative Colitis in Clinical Remission. Li, Z., Li, Z., Zhu, L., et al.[2022]

In a study of 17 patients with active ulcerative colitis, 6 weeks of prebiotic galactooligosaccharide (GOS) supplementation did not significantly reduce clinical scores or inflammation, but it did improve stool consistency, with normal stool proportions increasing from 49% to 70%.

The prebiotic treatment led to an increase in beneficial gut bacteria, specifically Bifidobacterium and Christensenellaceae, but this effect was only observed in patients with less active disease, suggesting that the benefits of prebiotics may vary based on the severity of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic Galactooligosaccharide Supplementation in Adults with Ulcerative Colitis: Exploring the Impact on Peripheral Blood Gene Expression, Gut Microbiota, and Clinical Symptoms. Wilson, B., Eyice, Ö., Koumoutsos, I., et al.[2021]

In a study of 25 patients with mild to moderate ulcerative colitis, a high dose of 15 g/day of inulin-type fructans significantly improved clinical outcomes, with 77% of patients showing a response compared to 33% in the lower dose group.

The benefits of inulin-type fructans were linked to increased production of butyrate, a beneficial short-chain fatty acid, rather than changes in the composition of gut bacteria, suggesting that metabolic shifts in the microbiota may be more crucial for improving ulcerative colitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin-type fructans improve active ulcerative colitis associated with microbiota changes and increased short-chain fatty acids levels. Valcheva, R., Koleva, P., Martínez, I., et al.[2020]

In a double-blind study involving 195 patients with quiescent ulcerative colitis, Bifidobacterium breve strain Yakult (BFM) did not significantly improve relapse-free survival compared to a placebo over 48 weeks, leading to the study's discontinuation due to lack of efficacy.

An exploratory analysis showed no impact of BFM on intestinal microbiota, and while three mild adverse events were reported, a direct causal relationship with the treatment could not be established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Bifidobacterium breve Fermented Milk in Maintaining Remission of Ulcerative Colitis. Matsuoka, K., Uemura, Y., Kanai, T., et al.[2018]

The study evaluated the effects of esters formed from prebiotics and short chain fatty acids on the gut microbiota of ulcerative colitis (UC) patients, using an in vitro fermentation model to analyze changes in microbial composition and SCFA production.

Results indicated that butyrylated fructooligosaccharides (B-FOS) and propionylated fructooligosaccharides (P-FOS) not only promoted beneficial bacteria like Bifidobacterium but also inhibited harmful bacteria, suggesting their potential to restore gut balance and reduce inflammation in UC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermentation patterns of prebiotics fructooligosaccharides-SCFA esters inoculated with fecal microbiota from ulcerative colitis patients. Chen, W., Tan, D., Yang, Z., et al.[2023]

Probiotics containing bifidobacteria have shown significant efficacy in inducing remission in patients with active ulcerative colitis (UC), with a relative risk of 1.73 when using FDA-recommended assessment scales.

No significant effects were found for maintaining remission in UC patients when comparing probiotics to placebo or mesalazine, highlighting the need for validated scales to accurately assess treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Probiotics, Prebiotic Inulin-Type Fructans, and Synbiotics in Human Ulcerative Colitis: A Systematic Review and Meta-Analysis. Astó, E., Méndez, I., Audivert, S., et al.[2020]

Arabino-oligosaccharides (AOS) derived from sugar beet pulp showed potential prebiotic effects similar to fructo-oligosaccharides (FOS) in promoting the growth of beneficial bacteria like Bifidobacterium and Lactobacillus in fecal samples from ulcerative colitis patients and healthy controls.

The fermentation of AOS led to increased production of acetate and a decrease in pH, suggesting that AOS could help improve inflammatory conditions in ulcerative colitis patients, although further human trials are necessary to confirm these health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro fermentation of sugar beet arabino-oligosaccharides by fecal microbiota obtained from patients with ulcerative colitis to selectively stimulate the growth of Bifidobacterium spp. and Lactobacillus spp. Vigsnæs, LK., Holck, J., Meyer, AS., et al.[2021]

References

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

Effects of Xylo-Oligosaccharide on the Gut Microbiota of Patients With Ulcerative Colitis in Clinical Remission. [2022]

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

Prebiotic Galactooligosaccharide Supplementation in Adults with Ulcerative Colitis: Exploring the Impact on Peripheral Blood Gene Expression, Gut Microbiota, and Clinical Symptoms. [2021]

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

Inulin-type fructans improve active ulcerative colitis associated with microbiota changes and increased short-chain fatty acids levels. [2020]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Fermentation patterns of prebiotics fructooligosaccharides-SCFA esters inoculated with fecal microbiota from ulcerative colitis patients. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Probiotics, Prebiotic Inulin-Type Fructans, and Synbiotics in Human Ulcerative Colitis: A Systematic Review and Meta-Analysis. [2020]

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

In vitro fermentation of sugar beet arabino-oligosaccharides by fecal microbiota obtained from patients with ulcerative colitis to selectively stimulate the growth of Bifidobacterium spp. and Lactobacillus spp. [2021]