A Study of the Potential for Polyethylene Glycol (Miralax) to Metabolize into Toxic Oxalate
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-008398
Sponsor Protocol Number: 14-008398
About this study
The purpose of this research study is to determine if the frequent use of polyethylene glycol (MiraLAX) may cause hyperoxaluria - an abnormally high level of oxalate in the urine.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Any individual ages 18 to 65
- Women who are post-menopausal or have had a hysterectomy will be considered eligible
- A subject will be considered eligible if she has no signs or symptoms of pregnancy and meets any one of the following criteria:
- Is ≤7 days after the start of normal menses
- Has not had sexual intercourse since the start of last normal menses
- Has been correctly and consistently using a reliable method of contraception
- Is ≤7 days after spontaneous or induced abortion
- Is within 4 weeks postpartum
- Is fully breastfeeding (exclusively breastfeeding or the vast majority [≥85%] of feeds are breastfeeds), amenorrheic, and <6 months postpartum
Exclusion Criteria
- Individuals at risk of enteric or secondary hyperoxaluria, ie have a history of
- Diarrhea
- Malabsorption (Crohn’s disease, Celiac disease, history of gastric sleeve or bypass)
- Primary hyperoxaluria
- Use orlistat, cholestyramine or other medications known to influence fat absorption
- Have an eGFR of below 60 mL/min/1.73m2 or a 24 hour urine oxalate level of > 0.46 mmol (the upper limit of normal per our laboratory)
- Women will be excluded if they are pregnant or could be pregnant at the time of the study
- Women must stop the study and notify the coordinator if there is a chance they may have become pregnant during the study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Dawn Milliner, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available