New Specialized Kombucha-Based Non-alcoholic Pasteurized Beverage Shows Favorable Profile of Short-Term Safety and Tolerability in Patients With Constipation.

Abstract

ObjectivesKombucha is a globally known beverage, perceived as “healthy”. It may be a basis for the development of new specialized beverages to increase dietary fiber consumption. However, safety and tolerability of the kombucha-based beverages is poorly studied yet. Aim: to assess short-term safety and tolerability of new kombucha-based pasteurized specialized non-alcoholic beverage, enriched with inulin.MethodsThis study (NCT05164861) enrolled subjects with constipation-predominant irritable bowel syndrome (per ROME IV). The subjects were randomized to receive either 220 ml of the non-alcoholic kombucha-based pasteurized beverage (KG), enriched with inulin (1.15 g/100ml) or 220 ml water (control group, CG), for 10 days. Except study product, subjects were advised to follow their usual diet. Organoleptic evaluation of the beverage; assessment of symptoms (abdominal pain/discomfort, abdominal fullness, bloating, heartburn) with the use of 5-point Likert scale; blood chemistry and hematology were performed before (BL) and on the 10th day of study (EOT). Patients were asked to report any adverse events during the study period.ResultsThere were 20 subjects in KG and 20 in CG groups. New specialized food product was well-tolerated, no SAE occurred during the study. No exacerbation of the pre-existing symptoms was observed in KG, including abdominal pain/discomfort (1.28 ± 0.56 vs 1.25 ± 0.56; p > 0.05), abdominal fullness (1.53 ± 0.69 vs 1.22 ± 0.47; p > 0.05), bloating (1.60 ± 0.64 vs 1.37 ± 0.60; p > 0.05), and heartburn (1.28 ± 0.62 vs 1.25 ± 0.52; p > 0.05) during the study. The rate of AEs was low (5%) and did not differ compared to CG. Mean integrative score of organoleptic evaluation of the beverage was good (91.0 ± 13.7%) with non-significant increase at EOT (94.2 ± 6.5%). No laboratory AE were observed.ConclusionsThis study suggest that new specialized kombucha-based drink enriched with inulin is well-tolerated, and has favorable safety profile.Funding SourcesRussian Science Foundation (research grant # 19-76-30,014).