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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether collagen peptides can ease gastrointestinal (GI) symptoms compared to a placebo. Researchers aim to determine if a single dose of collagen, mixed with water, can benefit individuals with stomach or digestive issues. It suits healthy adults who frequently experience GI discomfort and have maintained consistent eating and lifestyle habits for the past three months. Participants must be able to consume an animal-sourced powder product and agree to specific lifestyle guidelines during the study. As an unphased trial, this study allows participants to contribute to early-stage research that could provide new insights into managing GI discomfort.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that collagen peptides are generally safe for most people. Studies have found that taking up to 10 grams of collagen daily for up to six months is usually well-tolerated. Some individuals have reported minor side effects, such as rare stomach issues, but strong evidence does not link collagen to serious problems. However, individuals with chronic kidney disease should exercise caution, as collagen might not be safe for them. Overall, collagen appears to be a safe option for healthy adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using collagen peptides for gastrointestinal disorders because this treatment takes a unique approach compared to traditional options like proton pump inhibitors or antispasmodics. Unlike these medications, which primarily aim to reduce symptoms such as acid production or muscle spasms, collagen peptides may support the repair and strengthening of the gut lining itself. This natural, protein-based treatment is easy to administer—just dissolve in water—and could offer a more holistic solution that promotes long-term gut health.

What evidence suggests that collagen peptide might be an effective treatment for gastrointestinal symptoms?

This trial will compare the effects of Collagen Peptide with a placebo. Studies have shown that collagen peptides might help with digestive problems. In one study, a daily collagen peptide supplement reduced bloating and improved mild digestive symptoms in healthy women. Other research suggests that collagen can reduce inflammation, potentially calming an irritated gut. Some findings also indicate that collagen helps maintain the gut's protective barrier, which is important for overall gut health. These effects suggest that collagen peptides could benefit people with stomach discomfort. ^{3 6 7 8 9}

Who Is on the Research Team?

Nicoletta Virgilio

Principal Investigator

Rousselot BV

Are You a Good Fit for This Trial?

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

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

Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9198822/

Effect of a Daily Collagen Peptide Supplement on ... The use of a 20 g daily collagen peptide supplement may reduce bloating and improve mild digestive symptoms in otherwise healthy female adults.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06937801

To Assess the Effect of Collagen on Gastrointestinal ... This study will enroll healthy adults with perceived gastrointestinal symptoms to evaluate the effect of collagen peptides compared to placebo. Detailed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1756464620305028

Effect of a high-collagen peptide diet on the gut microbiota ... After 16S rDNA high-throughput sequencing, an average of 85,231 reads were detected per sample, and 80,095 effective reads were obtained through quality control ...

4. nature.com nature.com/articles/s41538-024-00367-7

Anti-inflammatory activity of collagen peptide in vitro and its ... The results show that collagen peptides demonstrated anti-inflammatory effects by inhibiting the secretion of pro-inflammatory cytokines and reducing oxidative ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.957391/full

Collagen peptide promotes DSS-induced colitis by ... In conclusion, our results showed that CP treatment in DSS-induced colitis can maintain the destruction of intestinal barrier function, change ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9941265/

The effects of collagen peptides on exercise-induced ... Collagen peptides did not modify exercise-induced changes in inflammation, GI integrity or subjective GI symptoms but LPS was higher in CON 2 h post-exercise.

7. vinmec.com vinmec.com/eng/blog/is-taking-collagen-harmful-to-the-kidneys-and-stomach-en

Is taking collagen harmful to the kidneys and stomach? For healthy kidneys, collagen is not harmful, but may be for those with CKD. Rare stomach issues have been reported, but no reliable evidence ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-1606/collagen-peptides

Collagen Peptides – Uses, Side Effects, and More When taken by mouth: Collagen peptides are possibly safe. Collagen peptides have been safely used in doses up to 10 grams daily for up to 6 months. Side effects ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2214799323000267

Food-derived collagen peptides: safety, metabolism, and ... CPs are safe, but the risks of excessive intake, harmful elements, and pathogenic agents should still be considered. Following gastrointestinal digestion, they ...