50 Participants Needed

Cimetidine Excretion During Lactation

MH
Overseen ByMary Hebert, PharmD, FCCP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how the drug cimetidine is processed and excreted in breast milk. Researchers seek to understand the activity of certain proteins in the mammary glands of healthy breastfeeding women. The study is recruiting healthy postpartum women who are not currently taking cimetidine or other medications that might interact with it. Participants will provide important insights into the safety and effects of drugs during lactation. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its benefits for more patients, offering participants a chance to contribute to safer medication use during breastfeeding.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants taking medications that interact with cimetidine or affect specific drug transporters. It's best to discuss your current medications with the trial team to see if any need to be stopped.

What is the safety track record for this treatment?

Research has shown that cimetidine is generally safe for breastfeeding mothers and their babies. Studies have found that only a small amount of cimetidine passes into breast milk, and no side effects have been reported in breastfed babies, particularly those older than two months.

A breastfeeding baby would receive about 6.7% of the cimetidine dose taken by the mother. This small amount is not expected to cause harm. Among over-the-counter heartburn medications, cimetidine is considered safe for breastfeeding mothers.

Overall, cimetidine is well-tolerated, and no negative effects have been reported in nursing infants.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about studying cimetidine excretion during lactation because it aims to provide crucial insights into how this medication transfers into breast milk. Unlike other treatments that focus on the direct therapeutic effects of drugs, this study focuses on understanding drug safety and exposure for breastfeeding infants. By exploring how much cimetidine is excreted into breast milk, the trial can help guide safer medication use for nursing mothers, potentially impacting prescribing practices and enhancing infant safety.

What evidence suggests that this treatment might be an effective treatment for drug excretion in breast milk?

Previous studies have shown that cimetidine effectively treats heartburn and ulcers by reducing stomach acid. Research indicates that cimetidine blocks certain signals in the stomach, lowering acid levels. Although this trial does not focus on treating a specific condition, it aims to understand how cimetidine enters breast milk and how the body processes it during breastfeeding. The study will involve healthy lactating women to help ensure the safe use of cimetidine for breastfeeding mothers. Overall, cimetidine has a proven history of effectively reducing stomach acid.

Who Is on the Research Team?

MH

Mary Hebert, PharmD, FCCP

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for healthy, lactating or pregnant women planning to breastfeed, aged 18-50, and their nursing infants between 3 weeks to 8 months old. Participants must not be on medications that could interact with the study drug.

Inclusion Criteria

I am a healthy woman aged 18-50, currently breastfeeding or planning to, with a nursing infant aged 3 weeks to 8 months.

Exclusion Criteria

Following multiple gestation (twins, triplets etc.)
You are a smoker.
Pregnancy
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of cimetidine 200 mg on each of 3 study days at different postpartum stages

6-8 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Drug Excretion in Breast Milk
Trial Overview The study is testing how Cimetidine (200 MG), a medication commonly used to treat heartburn and stomach ulcers, is excreted in breast milk at different times after childbirth.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Healthy Lactating WomenExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

Maternal pretreatment with cimetidine during lactation significantly inhibits drug metabolism in both mouse dams and their pups in a dose-dependent manner, with the highest dose (50 mg/kg/day) showing comparable inhibition levels in dams and female pups, but less effect on male pups.
Among the metabolic processes studied, aniline hydroxylase was the least affected by cimetidine, indicating that the impact of maternal drug exposure varies based on the specific metabolic pathway and the sex of the offspring.
Dose-related and other effects of maternal cimetidine pretreatment during lactation on drug metabolism in mouse dams and pups.Osuide, G., Wambebe, C., Ikediobi, CO., et al.[2018]
Cimetidine transfers into milk in both rabbits and rats, with a higher concentration in milk compared to serum, indicating that nursing offspring may be exposed to significant levels of the drug.
The mechanism of cimetidine transfer differs between species: in rabbits, it appears to be primarily through diffusion, while in rats, it may involve active transport, suggesting species-specific pharmacokinetics.
Pharmacokinetics of cimetidine during lactation: species differences in cimetidine transport into rat and rabbit milk.McNamara, PJ., Burgio, D., Yoo, SD.[2013]
A systematic review of seven studies involving 25 mother-infant pairs found that the relative infant dose of various antihistamines in breast milk is low, with all medications showing less than 5% exposure to breastfed infants, indicating a generally low risk of adverse effects.
Despite the low exposure levels, most antihistamine product labels in the EU and the US recommend avoiding use during breastfeeding due to insufficient evidence, highlighting a significant knowledge gap that calls for more research on the safety of antihistamines for breastfeeding women.
Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans: A systematic literature review.Ngo, E., Spigset, O., Lupattelli, A., et al.[2022]

Citations

Cimetidine - Drugs and Lactation Database (LactMed®) - NCBICimetidine would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.
Study Details | NCT06056583 | Drug Excretion in Breast MilkEach woman will receive a single oral dose of cimetidine 200 mg on each of 3 study days (3-5 weeks, 3-4 months, and 6-8 months postpartum) followed by serial ...
Breastfeeding and Medication SafetyAll currently available H2-blockers available OTC are considered safe to use during breastfeeding. Cimetidine should be considered the least ...
Treating heartburn and dyspepsia during breastfeedingCimetidine passes into breast milk in moderate amounts, although no side effects have been reported in breastfed infants. However because of ...
Cimetidine Excretion During LactationCimetidine is excreted into breast milk, but the amount ingested by a breastfeeding infant is estimated to be 6.7% of the maternal dose, which appears to be ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security