Feasibility of Transitioning Adults with Mild-to-Moderate Reflux from Proton Pump Inhibitors to a Patented Papaya–Oat Food Supplement: A Single-Arm Pilot Study

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Background: Proton pump inhibitors (PPIs) serve as efficacious therapies for acid-related conditions; nonetheless, the possibility of unwarranted prolonged usage has led to heightened focus on PPI management and suitable deprescribing practices. Investigating supportive non-pharmacological approaches after the cessation of PPIs is necessary. Objective: This single-arm pilot study evaluated the feasibility and acceptability of a structured transition from proton pump inhibitor (PPI) therapy to papaya–oat food supplementation with Caricol®-Gastro in adults with mild-to-moderate reflux/heartburn. Changes in patient-reported symptoms during supplementation were assessed as exploratory clinical outcomes. Adults with mild-to-moderate reflux/heartburn underwent a protocol-defined PPI treatment phase, followed by PPI discontinuation and five weeks of Caricol®-Gastro supplementation. Symptoms reported by patients were evaluated utilizing a tailored 15-item questionnaire right prior to supplementation and at Week 5. Feasibility results encompassed research finalization, compliance, fulfillment of the protocol-specified transition, and the necessity for symptom-associated PPI reinstatement. A 14-day observation period without products following the intervention evaluated the short-term incidence of symptoms after the cessation of supplementation. Results: All 39 persons who enrolled finished the trial. The average compliance with supplementation was 93.2%, and no participant ceased using Caricol®-Gastro due to exacerbation or recurrence of reflux/heartburn symptoms, nor did any require the reinitiation of protocol-allowed PPIs during the supplementation period. The average overall symptom score diminished from 37.38 (SD 2.88) before supplementation to 24.85 (SD 4.84) by Week 5, reflecting a mean within-participant alteration of −12.54 points (95% CI: −13.54 to −11.53; p < 0.001). Throughout the 14-day observation period following the intervention without product use, 11 subjects (28.2%) exhibited no symptoms, while 28 (71.8%) experienced symptoms on at most two occasions. Conclusions: The results support the feasibility and acceptability of the protocol-defined transition from PPI therapy to papaya–oat supplementation in this selected population. The noted decreases in symptoms within participants are preliminary and, due to the lack of a controlled design, cannot be causally linked to Caricol®-Gastro. These results advocate for additional assessment of the supplementation as a possible supporting approach after the clinically suitable cessation of PPIs in a sufficiently powered randomized controlled trial employing a validated patient-reported primary outcome.

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