Omeprazole for Digestive Health

Overseen By Tyler Churchward-Venne, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Pregnancy, Vegan diet, COVID-19, others

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how omeprazole, a common heartburn medication, affects protein digestion and absorption. It aims to determine if omeprazole alters the body's ability to absorb amino acids, the building blocks of protein, after eating. The findings could update nutrition guidelines for those using this medication, especially older adults who may need more protein for muscle health. The trial seeks healthy adults aged 50-60 with stable health and lifestyle habits. As an unphased trial, it offers participants the chance to contribute to important nutritional research that could benefit many.

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

The trial does not specify that you need to stop taking your current medications. However, you must have maintained stable use of medication and supplements for the last 3 months and agree to keep them stable throughout the study.

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

Research has shown that most people can take omeprazole without problems. Studies have found that the main side effects include headache, stomach pain, and diarrhea, but these are infrequent. Omeprazole, commonly used to lower stomach acid, is safe for treating heartburn and ulcers. While generally safe, consulting a doctor is wise if there are any concerns, especially for long-term use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Omeprazole is unique because it offers fast relief for digestive issues by reducing stomach acid production, often in just a few days. Unlike many other treatments that might take longer to show effects, omeprazole can provide quicker symptom relief. Researchers are excited about its potential to improve patient comfort and quality of life with a simple, once-daily capsule.

What is the effectiveness track record for omeprazole in treating digestive health issues?

Studies have shown that omeprazole effectively treats heartburn, acid reflux, and stomach ulcers. For instance, research found that 86% of patients with severe esophageal damage healed after using omeprazole. Another study demonstrated that a 20 mg dose of omeprazole once a day reduced heartburn symptoms more effectively than a lower dose or a placebo. Omeprazole lowers stomach acid, aiding in ulcer healing and prevention while relieving heartburn. This medication is generally well-tolerated and commonly used for these conditions. Participants in this trial will receive either a 20 mg dose of omeprazole or a placebo to evaluate its effectiveness further. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 50-60 who are generally healthy. It's not suitable for those with allergies to omeprazole, digestive system diseases, or conditions that affect protein metabolism. Participants must be able to attend two study visits and provide blood samples.

Inclusion Criteria

Has a BMI between 18.5 to 29.9 kg·m-2 at screening visit

In good general health as deemed by the investigator and able to consume the study product

Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures

Exclusion Criteria

Individuals who adhere to a diet that restricts consumption of dairy products

Currently or planning to be on a weight loss regimen during the study

Receipt or use of test products in another research study within 30 days prior to study visit 1 or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend two study visits at least one week apart, consuming a mixed meal with and without omeprazole, with blood samples collected to measure plasma amino acid concentrations.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and gastrointestinal tolerance.

120 days

What Are the Treatments Tested in This Trial?

Interventions

• Omeprazole

Trial Overview The study tests how a dose of Omeprazole taken before a meal affects the levels of amino acids in the blood compared to no medication. It's a crossover study where participants will experience both scenarios on different visits.

How Is the Trial Designed?

Group I: Omeprazole 20mg capsule Active Control 1 Intervention

Pharmaceutical Intervention: Omeprazole 20 mg capsule 1 dose = 1 capsule of Omeprazole 20mg 1 dose will be consumed per day for 5 days before the study visit. The participant will then also consume 1 dose on the day of the study visit in the laboratory environment.

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

BIO-CAT, Inc.

Industry Sponsor

Trials

6

Recruited

210+

Citations

1. gastrojournal.org gastrojournal.org/article/S0016-5085(00)70149-1/fulltext

The efficacy and safety of long-term omeprazole treatment ... 86% of patients with severe erosive esophagitis healed within 12 weeks of using 40 mg omeprazole. These data confirm the efficacy of this drug. The authors ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/485364

Efficacy of Omeprazole for the Treatment of Symptomatic ... Omeprazole, 20 mg once daily, was superior to omeprazole, 10 mg once daily, and to placebo in providing early and sustained resolution of heartburn.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539786/

Omeprazole - StatPearls - NCBI Bookshelf - NIH Omeprazole is a proton-pump inhibitor used to manage and treat several conditions, including uncomplicated heartburn, peptic ulcer disease, gastrointestinal ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10428080/

Effectiveness of Omeprazole in Acid Peptic Disease Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/9990554

Efficacy and Safety of Omeprazole for the Treatment of Acid ... Primary outcomes included improvement of APD symptoms and frequency of ulcer or erosion healing. Secondary outcomes included adverse events, ...

6. drugs.com drugs.com/omeprazole.html

Omeprazole Uses, Side Effects, Dosage, Warnings Omeprazole is used to treat excess stomach acid in conditions such as non cancerous stomach ulcers, gastroesophageal reflux disease (GERD), active duodenal ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/omeprazole-oral-route/description/drg-20066836

Omeprazole (oral route) - Side effects & dosage Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9897136/

Safety assessment of omeprazole use: a review - PMC Therefore, the data confirm that there is no evidence of clinical outcomes (safety and effectiveness) resulting from unapproved use of omeprazole, such as ...