A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes (NCT07379645) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
United States50 participantsStarted 2026-01-15
Plain-language summary
This decentralized, randomized, double-blind, placebo-controlled, two-period crossover study will evaluate whether PepZinGI® (zinc-L-carnosine) reduces food-triggered heartburn compared with placebo. Participants (N=50) complete two 1-week treatment periods (PepZinGI® and placebo) separated by a 2-week washout, for a total of 29 days. Primary outcomes are heartburn severity and frequency measured by the NutriScience Heartburn Questionnaire; secondary outcomes include PROMIS GI Reflux-13a, time to relief, rescue medication use, wearable-derived sleep metrics, Karolinska Sleep Scale, sleep diary entries, and satisfaction. All activities are remote through Alethios; no in-person visits.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥21 years
* Self-reported food-triggered heartburn with known trigger foods
* Heartburn at least once per week
* Willing to avoid OTC/supplement heartburn treatments during study (calcium-carbonate rescue allowed but must be logged and not used during hurdle-meal day/night)
* Able to complete electronic surveys and adhere to procedures
* Access to or willingness to use a compatible wearable device
Exclusion Criteria:
* Clinician-diagnosed GERD, UC, Crohn's, or IBD
* Prescribed drugs for heartburn/digestive conditions
* Heartburn less than once per week or daily throughout the month
* More than 1 alcoholic drink/day on average during study
* Recreational drug use during study
* Known allergy to zinc, L-carnosine, or study ingredients
* Pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a supplement called PepZinGI® and measured both heartburn symptoms and sleep quality — do you think the connection between my heartburn and my sleep problems is worth exploring as part of my treatment plan?
2The trial used specific questionnaires like the PROMIS-Gastroesophageal Reflux scale and the Karolinska Sleep Scale to track outcomes — would those tools be useful for me to use at home to track whether any treatment is actually working?
3Since this was listed as Phase NA and involved a supplement rather than a prescription drug, how confident can we be in the safety and effectiveness data compared to a standard pharmaceutical trial for heartburn?
4The trial has been completed — do you know if the results have been published yet, and if so, what did they actually find about whether PepZinGI® helped with heartburn frequency and severity?
5Before considering anything from this trial, should I try established treatments for my heartburn first, and how would we decide if something like PepZinGI® might be worth adding to my routine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a
Timeframe: Baseline, Day 8, and Day 29
2
Participant sleep quality measured by Karolinska Sleep Scale
Timeframe: Baseline, Day 8, and Day 29
3
Heartburn severity measured by NutriScience Heartburn Questionnaire