Medical Food (SPHi) for Ulcerative Colitis

Overseen By Elena Harnish, MA

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Must not be taking: Corticosteroids

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children. The main question it aims to answer is: 1) How well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fCal) in ulcerative colitis as compared to the historical active therapy levels of fCal? Participants will take a specified dose of the medical food in water each day for 12 weeks. The level of fCal will be measured through a stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. The levels of fCal will be compared across the 16 weeks and compared with levels before the new medical food was taken.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on stable maintenance therapy and not use oral or topical corticosteroids.

What data supports the effectiveness of the treatment Soluble Protein Hydrolysate (SPHi) for Ulcerative Colitis?

Research on mice with colitis shows that Soluble Protein Hydrolysate (SPH) can reduce inflammation and tissue damage in the gut. It works by lowering harmful immune responses and boosting protective ones, suggesting it might help manage inflammatory bowel diseases like ulcerative colitis. ^{1 2 3 4 5}

Is Soluble Protein Hydrolysate (SPHi) safe for humans?

Research on Soluble Protein Hydrolysate (SPHi) in mice shows it has anti-inflammatory and anti-oxidative effects, suggesting it may be safe. However, specific human safety data is not provided in the available studies. ^{1 3 4 6 7}

How is the treatment Soluble Protein Hydrolysate (SPHi) unique for ulcerative colitis?

Soluble Protein Hydrolysate (SPHi) is unique because it is derived from salmon offcuts and contains bioactive peptides with anti-inflammatory and antioxidant properties, which help reduce inflammation and promote healing in the gut. Unlike traditional medications, SPHi is a dietary intervention that can be consumed as part of a regular diet, potentially offering a more natural and well-tolerated approach to managing ulcerative colitis. ^{1 3 4 7 8}

Eligibility Criteria

This trial is for children with confirmed ulcerative colitis who are on a stable maintenance therapy but not using oral or topical corticosteroids. It's designed to see if a new medical food can manage their condition.

Inclusion Criteria

My child has ulcerative colitis and is on a stable treatment plan.

Exclusion Criteria

I am a child with ulcerative colitis and use steroids for ongoing treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a specified dose of the medical food in water each day for 12 weeks

12 weeks

3 visits (in-person) at baseline, during, and end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with fecal calprotectin levels measured

4 weeks

1 visit (in-person) at 16 weeks

Treatment Details

Interventions

• Soluble protein hydrolysate (SPHi)

Trial Overview The study tests how well the Soluble Protein Hydrolysate (SPHi) medical food reduces inflammation in pediatric ulcerative colitis patients by lowering fecal calprotectin levels over a period of 16 weeks.

Participant Groups

Group I: Standard Active Therapy plus SPHi Experimental Treatment 1 Intervention

Participants will undergo the standard active therapy of ulcerative colitis plus the addition of the ProGo medical food.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

References

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

Soluble Protein Hydrolysate Ameliorates Gastrointestinal Inflammation and Injury in 2,4,6-Trinitrobenzene Sulfonic Acid-Induced Colitis in Mice. [2022]

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

An oral supplement enriched with fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis: a randomized, controlled trial. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Production of Corn Protein Hydrolysate with Glutamine-Rich Peptides and Its Antagonistic Function in Ulcerative Colitis In Vivo. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Fish Sidestream-Derived Protein Hydrolysates Suppress DSS-Induced Colitis by Modulating Intestinal Inflammation in Mice. [2021]

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

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

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

Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Protective effects of Lacticaseibacillus rhamnosus Hao9 on dextran sulphate sodium-induced ulcerative colitis in mice. [2022]

8. Iran pubmed.ncbi.nlm.nih.gov

Effects of an Oral Supplementation of Germinated Barley Foodstuff on Serum CRP Level and Clinical Signs in Patients with Ulcerative Colitis. [2021]