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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively a new medical food can manage inflammation in children with ulcerative colitis. The treatment involves taking a protein-rich supplement called soluble protein hydrolysate (SPHi) daily for 12 weeks, alongside standard therapy. Researchers will measure changes in an inflammation marker called fecal calprotectin (fCal) through stool samples. Children diagnosed with ulcerative colitis who are on stable maintenance therapy (without corticosteroids) might be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research on Soluble Protein Hydrolysate (SPHi) in mice has shown it may reduce inflammation and protect cells from damage. This suggests potential safety for humans, but further research is necessary. Previous animal studies have not identified any major side effects. However, as this is an early-phase study, the primary goal is to assess its safety in humans.

Currently, researchers are testing SPHi in people to determine its effectiveness in managing inflammation in ulcerative colitis, a condition that causes swelling in the digestive tract. Since the study is in its initial stages, the main focus is on assessing tolerance to SPHi and monitoring for any side effects. While early animal study results are promising, this trial is crucial to confirm its safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs and immunosuppressants, the soluble protein hydrolysate (SPHi) being studied is a medical food. SPHi is derived from proteins broken down into smaller peptides, which may help reduce inflammation in a more natural way. Researchers are excited about SPHi because it offers a unique approach by potentially soothing the gut lining and modulating the immune response without relying on harsh chemicals. This could lead to fewer side effects and a more balanced treatment option for patients.

What evidence suggests that this medical food might be an effective treatment for ulcerative colitis?

Research has shown that Soluble Protein Hydrolysate (SPHi) might help reduce inflammation and tissue damage in people with ulcerative colitis. Studies in mice found that SPHi can lower harmful inflammation in the gut and protect the colon by reducing the number of inflammatory cells that cause damage. Although these results come from animal studies, they suggest that SPHi could also help manage inflammation in humans with ulcerative colitis. More research is needed to confirm these effects in people, but early signs are promising. Participants in this trial will receive standard active therapy for ulcerative colitis, with the addition of SPHi, to evaluate its potential benefits. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9496120/

Soluble Protein Hydrolysate Ameliorates Gastrointestinal ... In conclusion, SPH treatment significantly reduces colon tissue injury in the mouse TNBS acute colitis model by alleviating inflammatory cell ...

2. withpower.com withpower.com/trial/phase-1-colitis-11-2023-30e35

Medical Food (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 ...

3. mdpi.com mdpi.com/2218-273X/12/9/1287/review_report

Soluble Protein Hydrolysate Ameliorates Gastrointestinal ... This is a very well-planned and well-executed study with valuable results, in which it was found that the SPH protein solution has a protective ...

4. consensus.app consensus.app/papers/soluble-protein-hydrolysate-ameliorates-tao-wang/2ae2356213fe5456979a33d9357f21ba/

Soluble Protein Hydrolysate Ameliorates Gastrointestinal ... Key takeaway: 'Soluble protein hydrolysate (SPH) reduces inflammation and colon tissue damage in mice with TNBS-induced colitis, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10610201/

Whey Protein Hydrolysate Exerts Anti-Inflammatory Effects ... The results indicated that WPH intervention for 37 days was effective in delaying the development of colonic inflammation, and high doses of ...

6. mdpi.com mdpi.com/2218-273X/12/9/1287

Soluble Protein Hydrolysate Ameliorates Gastrointestinal ... This study aimed to investigate whether SPH ameliorates gastrointestinal injury in 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced mouse colitis model.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459238/

Tamarind Seed Polysaccharide Hydrolysate Ameliorates ... Tamarind seed polysaccharide hydrolysate ameliorates dextran sulfate sodium-induced ulcerative colitis via regulating the gut microbiota.

8. sciencedirect.com sciencedirect.com/science/article/pii/S3050620425000466

Next-generation non-animal models for inflammatory ... Experimental studies suggest that MPs can impair intestinal barrier integrity, disrupt the gut microbiome, and promote metabolic disturbances, thereby ...