Creatine Monohydrate for Ulcerative Colitis

Overseen By Lucy Smigiel, MPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must be taking: Mesalamine, Thiopurines

Must not be taking: Anti-TNF, Corticosteroids, NSAIDs, others

Disqualifiers: Pregnancy, Severe UC, Major comorbidities, 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 how creatine monohydrate affects inflammation in people with ulcerative colitis, a type of inflammatory bowel disease. Creatine, a natural substance, provides energy to cells and may strengthen the gut's barrier, reducing inflammation. Participants will receive either creatine or a placebo to determine if creatine can help manage symptoms. This trial may suit individuals with mild to moderate ulcerative colitis who manage it with stable doses of medications like mesalamine or thiopurines. As an Early Phase 1 trial, this research aims to understand how creatine monohydrate works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial allows certain medications like mesalamine and thiopurines if they have been used at stable doses for a specified period. However, you must stop using over-the-counter supplements and certain medications like NSAIDs and ACE inhibitors two weeks before and during the study.

Is there any evidence suggesting that creatine monohydrate is likely to be safe for humans?

Research has shown that creatine monohydrate is usually safe for healthy adults when taken in small amounts, about 3 grams per day. Some individuals might experience minor side effects, such as stomach discomfort. In studies where participants with ulcerative colitis took 21 grams daily, scientists continue to investigate its safety and effectiveness. Creatine is a natural substance in the body and is also found in foods like meat and fish. Overall, it appears to be well-tolerated, but ongoing research will provide more detailed information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for inflammatory bowel disease (IBD), which typically involve anti-inflammatory medications or immunosuppressants, creatine monohydrate offers a novel approach by targeting the intestinal creatine kinase system. This system is thought to play a role in cellular energy metabolism, which is crucial for maintaining healthy gut function. Researchers are excited about this treatment because it might address IBD in a way that focuses on improving energy metabolism in intestinal cells, potentially offering a new avenue for managing the disease.

What evidence suggests that creatine monohydrate might be an effective treatment for ulcerative colitis?

Research has shown that creatine monohydrate might help ease symptoms of ulcerative colitis, a type of inflammatory bowel disease. This trial will administer creatine monohydrate to some participants to evaluate its effectiveness. In one case, creatine improved both the symptoms and the condition of the colon in a patient with ulcerative colitis. Additionally, animal studies found that creatine lessened the severity of colitis symptoms. Creatine provides energy to cells in the colon, supporting a strong barrier to prevent inflammation. Early findings suggest it could be a promising option for managing ulcerative colitis. ^{1 2 5 6 7}

Who Is on the Research Team?

Mark Gerich, MD

Principal Investigator

University of Colorado Denver, Division of Gastroenterology

Are You a Good Fit for This Trial?

Inclusion Criteria

Allowed concomitant medications will include mesalamine compounds if used for at least 8 weeks and at a stable dose for at least 4 weeks, as well as thiopurines (azathioprine, 6-mercaptopurine) if used at a stable dose for at least 3 months.

Exclusion Criteria

Diagnosis of severe UC (Mayo Score > 10)

You have taken medications called anti-TNF agents or oral/rectal corticosteroids recently.

Evidence or history of toxic megacolon

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive creatine monohydrate or placebo for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants from the placebo arm may opt into continuation of creatine monohydrate treatment for 8 weeks

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Creatine monohydrate
• Placebo

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 1 Intervention

6 patients with mild-moderate ulcerative colitis treated with creatine monohydrate 21 grams per day in three divided doses taken with water for 8 weeks.

Group II: Optional Open-Label Treatment arm Experimental Treatment 1 Intervention

Up to 6 patients, who were randomized to the placebo arm, will be given the option to continue with open-label creatine monohydrate treatment at 21 grams per day in three divided doses, taken with water, for 8 weeks. Only non-invasive testing will be performed.

Group III: Placebo arm Placebo Group 1 Intervention

6 patients with mild-moderate ulcerative colitis treated with placebo (matching creatine monohydrate) 21 grams per day in three divided doses taken with water for 8 weeks.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Creatine monohydrate is effective in enhancing athletic performance, particularly for activities involving repeated short bursts of high-intensity effort, with significant improvements in force production across various sports, ages, and sexes.

While creatine shows benefits for activities like jumping, sprinting, and cycling, it does not significantly aid in preventing muscle damage or soreness, and there is limited evidence for its effectiveness in endurance activities. Additionally, no strong evidence suggests adverse effects from short-term use, but long-term safety remains unstudied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation and exercise performance: recent findings. Bemben, MG., Lamont, HS.[2022]

Creatine monohydrate is generally considered safe for healthy adults at a daily intake of 3 grams, with some minor side effects like gastrointestinal issues and muscle cramps reported.

While most creatine forms are unlikely to pose safety concerns, there are specific safety concerns associated with creatine orotate, creatine phosphate, and magnesium creatine chelate, indicating that not all creatine supplements are equally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine and creatine forms intended for sports nutrition. Andres, S., Ziegenhagen, R., Trefflich, I., et al.[2018]

A systematic review of 29 studies involving 951 female participants found no serious adverse outcomes or deaths associated with creatine monohydrate (CrM) supplementation, indicating it is safe for use in women.

There were no significant differences in total adverse events, gastrointestinal issues, or weight gain between those taking CrM and those not, suggesting that CrM does not increase the risk of these complications in females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis. de Guingand, DL., Palmer, KR., Snow, RJ., et al.[2021]

Creatine supplementation significantly increases creatine levels in vegetarians, often surpassing those found in omnivores, and enhances muscle mass, strength, and endurance, making it beneficial for vegetarian athletes.

While creatine improved various physical and cognitive performance metrics in vegetarians, the evidence on whether it enhances exercise performance more than in omnivores remains mixed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Creatine Supplementation for Vegetarians Compared to Omnivorous Athletes: A Systematic Review. Kaviani, M., Shaw, K., Chilibeck, PD.[2020]

Creatine monohydrate is an effective sports supplement that helps maintain high-energy phosphate levels during exercise, leading to benefits like increased muscle mass and potential neural protection.

While creatine supplementation has many positive effects, there are concerns about side effects such as muscle cramping and the presence of impurities, which warrant careful consideration of its safety and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine: are the benefits worth the risk? Brudnak, MA.[2013]

In a pilot study with 81 patients and a follow-up study with 21 patients, creatine monohydrate supplementation significantly increased strength measures, including handgrip and knee extensor strength.

The treatment involved administering 10 g daily for 5 days, followed by 5 g daily for another 5 days, demonstrating that short-term creatine use can effectively enhance high-intensity strength in individuals with neuromuscular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine monohydrate increases strength in patients with neuromuscular disease. Tarnopolsky, M., Martin, J.[2019]

Creatine monohydrate effectively enhances muscle performance during short-duration, high-intensity exercises, with a recommended loading dose of 0.3 g·kg·d for 5 to 7 days followed by a maintenance dose of 0.03 g·kg·d for 4 to 6 weeks, although loading is not strictly necessary.

Creatine is generally safe with few side effects, primarily causing transient water retention; however, there are concerns about potential liver and kidney complications when taken in high doses or combined with other supplements over extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation. Hall, M., Trojian, TH.[2016]

In a study involving 36 resistance-trained individuals, traditional creatine monohydrate (CrM) supplementation was found to be more effective than buffered creatine (KA) in increasing muscle creatine content and improving strength, with no significant differences in side effects reported between the two forms.

The results showed that neither the recommended lower dose of KA nor the higher equivalent loading dose provided any additional benefits over CrM, challenging claims that buffered creatine is superior in efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A buffered form of creatine does not promote greater changes in muscle creatine content, body composition, or training adaptations than creatine monohydrate. Jagim, AR., Oliver, JM., Sanchez, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8145094/

Creatine Supplementation for Patients with Inflammatory ... Creatine Supplementation in One Single Case of Crohn's Disease Improved Both Symptomatic and Endoscopic Characteristics of Ulcerative Colitis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02463305

Study Details | NCT02463305 | Therapeutic Modulation of ... Study Overview. Brief Summary. This study plans to learn more about the effects that creatine monohydrate has on disease activity in ulcerative colitis.

3. withpower.com withpower.com/trial/early-phase-1-colitis-2022-ac32f

Therapeutic Modulation of the Intestinal Creatine Kinase ... A systematic review of 29 studies involving 951 female participants found no serious adverse outcomes or deaths associated with creatine monohydrate (CrM) ...

4. pubs.rsc.org pubs.rsc.org/en/content/articlehtml/2025/fo/d5fo01620g

Creatine differently prevents chronic colitis-induced motor ... The results showed that in rats with colitis, oral creatine supplementation reduced the severity of colitis symptoms and prevented motor ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33922654/

Creatine Supplementation for Patients with Inflammatory ... A current pilot clinical trial that incorporates the use of oral Cr at a dose of 2 × 7 g per day, over an initial period of 2 months in conjunction with ...

6. researchgate.net researchgate.net/publication/351251502_Creatine_Supplementation_for_Patients_with_Inflammatory_Bowl_Diseases_A_Scientific_Rationale_for_a_Clinical_Trial

Creatine Supplementation for Patients with Inflammatory ... ... safety and efficacy of creatine monohydrate for. patients with ulcerative colitis. (A) Creatine monotherapy trial: In addition to the current study mentioned ...

7. healthline.com healthline.com/health/ulcerative-colitis/creatine-ulcerative-colitis

Creatine for Ulcerative Colitis: Does It Treat Symptoms? Emerging research suggests that creatine supplements may help improve symptoms of ulcerative colitis and other forms of inflammatory bowel disease.