Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease

What Was Tested

In this phase 4 trial, researchers set out to test Carnosine.

Gastroesophageal reflux disease (GERD), according to the Montreal classification, is defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications.

GERD complications may be life threatening and range from reflux esophagitis to Barrett's oesophagus and, eventually, adenocarcinoma.

It had two arms (groups): A (experimental) and B (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

A comparison with a placebo is necessary, as GERD symptoms may be heavily influenced by the nocebo/placebo effect.

This is a post-marketing, single center, double-blind, and randomized, placebo-controlled, parallel study.

Patients with GERD treated with an 8-week cours of proton pump inhibitors will be randomize and receive either Zinc-l-carnosine or placebo for 12-week.

GERD symptoms will be assessed with a questionnaire (modified GERD questionnaire by Locke) monthly for 12 weeks and after a 4-week wash-out.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent to participate. Be male or female patients ≥ 18 years old, with an established diagnosis of GERD. Have been treated with an 8-week course of PPI (as per gold-standard treatment of GERD) before entering the study.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: any medical condition that requires chronic therapy with ppis or h2 antagonists; anti-acid agents must be discontinued within the study period; oesophageal motility disorders; allergy or intolerance to hepilor® (it contains parahydroxybenzoate that may cause allergies).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Carnosine.

Those kept unaware of assignments: participant and investigator.

It started in 2018-11-22 with completion listed for 2020-04-01.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Gastroesophageal reflux disease (GERD) remission (time frame: 4 weeks). Gastroesophageal reflux disease (GERD) remission (time frame: 8 weeks). Gastroesophageal reflux disease (GERD) remission (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example 36 item short form health survey and Sustained GERD remission.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carnosine in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.