Collagen for Gastrointestinal Disorder

Overseen By Stephanie Recker

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rousselot BVBA

Disqualifiers: Pregnancy, Diabetes, Hypertension, IBS, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

116 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you should maintain consistent medication intake throughout the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Collagen Peptide for gastrointestinal disorders?

Research shows that collagen peptides can help improve the function of the intestinal barrier, which is important for gut health. In a study, collagen peptides were found to strengthen the connections between cells in the gut lining, potentially helping with conditions like inflammatory bowel disease. ^{1 2 3 4 5}

Is collagen safe for human use?

Collagen has a long history of being safe and effective, with minimal tissue reaction and is biodegradable. It has been used in various studies, including those for joint pain, without significant safety concerns. ^{4 6 7 8 9}

How does collagen peptide treatment differ from other treatments for gastrointestinal disorders?

Collagen peptides are unique in treating gastrointestinal disorders because they may help protect the intestinal lining and reduce inflammation by modulating gut bacteria and immune responses. Unlike traditional treatments, collagen peptides are derived from natural sources like fish or bovine collagen and may offer additional benefits such as antioxidation and anti-apoptosis (preventing cell death) effects. ^{7 9 10 11 12}

What is the purpose of this trial?

This study will enroll healthy adults with perceived gastrointestinal symptoms to evaluate the effect of collagen peptides compared to placebo.

Research Team

Nicoletta Virgilio

Principal Investigator

Rousselot BV

Eligibility Criteria

Healthy adults aged 18-64 with gastrointestinal discomfort, BMI of 18.0 to 34.9, who've kept a consistent diet and lifestyle for the past three months are eligible. They must not have chronic diseases like inflammatory conditions or cancer within five years, no recent substance abuse, and agree to contraceptive use.

Inclusion Criteria

I've kept my diet, medication, and lifestyle the same for the last 3 months.

I have GI symptoms with a moderate severity score.

Agree to avoid anal penetration for 72 h prior to each fecal sample collection

Exclusion Criteria

I have a long-term inflammatory condition like rheumatoid arthritis.

I have been cancer-free for over 5 years, except for skin or cervical cancer.

History of alcohol or substance abuse in the 12 months prior to screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either collagen peptides or placebo to assess the effect on gastrointestinal discomfort and other health parameters

8 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Collagen Peptide
• Placebo

Trial Overview The trial is testing whether collagen peptides can reduce gastrointestinal symptoms in healthy adults compared to a placebo. Participants will consume either the collagen product or placebo and their GI comfort will be monitored.

Participant Groups

Group I: Collagen Peptide Active Control 1 Intervention

Dissolve in water, single dose, 10 g

Group II: Placebo Placebo Group 1 Intervention

single dose

Who Is Running the Clinical Trial?

Rousselot BVBA

Lead Sponsor

Trials

8

Recruited

220+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Findings from Research

In a 6-month study involving 200 patients aged 50 and older with joint pain, collagen hydrolysate at 1200 mg/day significantly increased the percentage of clinical responders (51.6%) compared to placebo (36.5%), indicating its potential efficacy in improving joint pain.

No significant safety or tolerability issues were reported between the collagen hydrolysate and placebo groups, suggesting that the supplement is safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of collagen hydrolysate in articular pain: a 6-month randomized, double-blind, placebo controlled study. Bruyère, O., Zegels, B., Leonori, L., et al.[2022]

Collagen-based medical products are safe and effective for delivering drugs and biologics, thanks to their biodegradable nature and minimal tissue reaction.

Regulatory requirements for collagen products are evolving, particularly concerning safety standards for animal-derived materials, which must address risks like Transmissible Spongiform Encephalopathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global regulatory registration requirements for collagen-based combination products: points to consider. O'Grady, JE., Bordon, DM.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled, randomised, clinical study on the effectiveness of collagen peptide on osteoarthritis. [2015]

2. Japan pubmed.ncbi.nlm.nih.gov

[Effect of collagen peptides on skeletal muscle mass in the elderly: An interventional study examining oral nutrition support for patients in a recovery-phase rehabilitation ward]. [2020]

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

Collagen peptides ameliorate intestinal epithelial barrier dysfunction in immunostimulatory Caco-2 cell monolayers via enhancing tight junctions. [2017]

4. Scotland pubmed.ncbi.nlm.nih.gov

Effect of collagen hydrolysate in articular pain: a 6-month randomized, double-blind, placebo controlled study. [2022]

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

Oral type II collagen treatment in early rheumatoid arthritis. A double-blind, placebo-controlled, randomized trial. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Global regulatory registration requirements for collagen-based combination products: points to consider. [2019]

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

Identification and Structure-Activity Relationship of Intestinal Epithelial Barrier Function Protective Collagen Peptides from Alaska Pollock Skin. [2020]

8. Japan pubmed.ncbi.nlm.nih.gov

[Bone and Nutrition. Functional foods for bone and cartilage tissues : Evidence for the action of collagen peptides]. [2015]

9. Canada pubmed.ncbi.nlm.nih.gov

Improvement of activity-related knee joint discomfort following supplementation of specific collagen peptides. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Anti-Inflammatory Effect of Bovine Bone-Gelatin-Derived Peptides in LPS-Induced RAW264.7 Macrophages Cells and Dextran Sulfate Sodium-Induced C57BL/6 Mice. [2022]

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

Protective Effects of Small-Molecule Oligopeptides Isolated from Tilapia Fish Scale on Ethanol-Induced Gastroduodenal Injury in Rats. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Collagen peptide promotes DSS-induced colitis by disturbing gut microbiota and regulation of macrophage polarization. [2022]