1. Efficacy and Safety of a Novel Therapeutic of Natural Origin (NTN) in Adult Patients with Lactose Intolerance: A Multicenter, Randomized, Crossover, Double-Blind, Placebo-Controlled Study
- Author
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Corina Pop, Ioan Sporea, Javier Santos, Nicolae Tudor, Nicoleta Tiuca, Institut Català de la Salut, [Pop C] Department of Gastroenterology and Internal Medicine, Clinical Emergency University Hospital, Bucharest, Romania. [Sporea I] Department of Gastroenterology, Clinical Emergency University Hospital, Timisoara, Romania. [Santos J] Laboratori de Neuro-Immuno-Gastroenterologia, Unitat de Recerca en l’Aparell Digestiu, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Servei d’Aparell Digestiu, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Tudor N] Department of Gastroenterology, Elias University Clinical Hospital, Carol Davila University, Bucharest, Romania. [Tiuca N] Department of Internal Medicine, Clinical Emergency University Hospital, Str. Splaiul Independentei 169, Sector 5, Bucharest, Romania, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
Health (social science) ,Digestive System Diseases::Gastrointestinal Diseases::Intestinal Diseases::Malabsorption Syndromes::Lactose Intolerance [DISEASES] ,afecciones patológicas, signos y síntomas::signos y síntomas::afecciones patológicas, signos y síntomas::signos y síntomas::signos y síntomas digestivos::dolor abdominal [ENFERMEDADES] ,diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Plant Science ,Intolerància a la lactosa ,enfermedades del sistema digestivo::enfermedades gastrointestinales::enfermedades intestinales::síndromes de malabsorción::intolerancia a la lactosa [ENFERMEDADES] ,Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Health Professions (miscellaneous) ,Microbiology ,Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Abdominal Pain [DISEASES] ,Other subheadings::Other subheadings::/diet therapy [Other subheadings] ,Avaluació de resultats (Assistència sanitària) ,Otros calificadores::Otros calificadores::/dietoterapia [Otros calificadores] ,lactose intolerance ,novel therapeutic of natural origin ,hydrogen breath test ,food intolerance ,intestinal barrier ,Food Science ,Dietoteràpia - Abstract
Food intolerance; Intestinal barrier; Natural therapeutic Intolerància alimentària; Barrera intestinal; Terapèutica natural Intolerancia alimentaria; Barrera intestinal; Terapéutica natural Background: Film-forming substances, such as natural polysaccharides (NP) and pea proteins (PP), act as a protective barrier for treating various gastrointestinal conditions. We assessed the efficacy and safety of a novel therapeutic of natural origin (NTN) containing NP and PP for symptomatic treatment of lactose intolerance. Methods: In this multicenter, randomized, double-blind, parallel-group study, patients with lactose intolerance received NTN (n = 30) or placebo (n = 30) for 7 days, then the alternate treatment for 7 days. Patients rated their gastrointestinal symptoms using a 7-point Likert scale. The lactose hydrogen breath test was used to assess exhaled hydrogen. Results: NTN as primary or crossover treatment significantly improved patient-reported symptoms of bloating, distension, and abdominal pain. Abdominal pain also improved under primary treatment with placebo. Primary treatment with NTN, but not placebo, normalized mean exhaled hydrogen levels. In the group allocated initially to placebo, crossover to NTN attenuated the increase in hydrogen production. No treatment-related adverse effects were reported in either group. Conclusions: Subjective improvements in bloating, distension, and abdominal pain with NTN were supported by objective evidence of hydrogen production normalization. NTN appears to be a useful alternative to lactose avoidance or enzyme replacement in patients with lactose intolerance. The study was sponsored by Novinthetical Pharma SA, Lugano, Switzerland.
- Published
- 2022