ORIGINAL ARTICLE   Free access

Minerva Gastroenterology 2023 March;69(1):123-7

DOI: 10.23736/S2724-5985.22.03282-X

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

Efficacy of a new nutraceutical formulation: L-tryptophan, probiotics, charcoal, chamomile, mint, and licorice (COLONIR®) in the improvement of gastrointestinal symptoms in subjects with irritable bowel syndrome

Giulia FIORINI ¹, Ilaria M. SARACINO ², Matteo PAVONI ², Bruno NIPOTE ³, Raffaele COLUCCI ⁴, Pietro CAPONE ⁵, Angela SANNINO ⁶, Fabrizio FORTE ⁷, Emiliano DE VERGORI ⁸, Mario BRANCACCIO ⁹, Maurizio CESAREO ¹⁰, Giovanni CASELLA ¹¹, Gaetano C. MORREALE ¹², Leonilde BONFRATE ¹³, Piero PORTINCASA ¹³, Massimo VINCENZI ¹⁴, Carmelo COTTONE ¹⁵, Vittorio M. ORMANDO ¹⁶, Natale SCALISE ¹⁷, Paulin F. LAWSON ¹⁸, Osvaldo BURATTINI ¹⁹, Amedeo MONTALE ²⁰,
Francesco LUZZA ²¹, Mauro ROSSI ²², Riccardo VANNI ²³, Rosamaria BOZZI ²⁴, Giuseppina VINCOLI ²⁵, Nicoletta STEFANI ²⁶, Claudio BORGHI ², Dino VAIRA ² ✉

¹ IRCCS University Hospital of Bologna, Bologna, Italy; ² Department of Surgical and Medical Sciences, University of Bologna, Bologna, Italy; ³ Unit of Surgery, Lagonegro Hospital, AOR S. Carlo, Potenza, Italy; ⁴ SC Foligno Hospital, USL Umbria2, Foligno, Perugia, Italy; ⁵ Unit of Gastroenterology and Digestive Endoscopy, Maresca Hospital, Torre del Greco, Naples, Italy; ⁶ Unit of Gastroenterology and Digestive Endoscopy, Santa Maria della Pietà Hospital, Nola, Naples, Italy; ⁷ UOSD of Interventional Gastroenterology, Madonna delle Grazie Hospital, Matera, Italy; ⁸ Unit of Gastroenterology and Digestive Endoscopy, G.B. Morgagni - L. Pierantoni Hospital, Forlì, Forlì-Cesena, Italy; ⁹ Unit of Gastroenterology and Digestive Endoscopy, S. Maria delle Croci Hospital, Ravenna, Italy; ¹⁰ Unit of Gastroenterology, Tirrenia Hospital, Belvedere Marittimo, Cosenza, Italy; ¹¹ Private Practitioner in General Medicine - Gastroenterology, Monza, Monza-Brianza, Italy; ¹² Unit of Gastroenterology, Ospedali Riuniti S. Elia/Raimondi, Caltanissetta, Italy; ¹³ Department of Biomedical Sciences and Human Oncology, University of Bari Aldo Moro, Bari, Italy; ¹⁴ Unit of Gastroenterology and Digestive Endoscopy, S. Pier Damiano Hospital, Faenza, Ravenna, Italy; ¹⁵ Private Practitioner in General Medicine - Gastroenterology, Palermo, Italy; ¹⁶ Unit of Gastroenterology, San Giuseppe Moscati Hospital, Avellino, Italy; ¹⁷ Department of Digestive Endoscopy, ANMI Rossano Center, Cosenza, Italy; ¹⁸ Unit of Gastroenterology and Digestive Endoscopy, Beato Matteo Clinical Institute, Vigevano, Pavia, Italy; ¹⁹ Unit of Gastroenterology II, IRCCS Saverio De Bellis, Castellana Grotte, Bari, Italy; ²⁰ Unit of Gastroenterology and Digestive Endoscopy, E.O. Ospedali Galliera, Genoa, Italy; ²¹ Unit of Pathophysiology of the Digestive System, Mater Domini Germaneto, Catanzaro, Italy; ²² Unit of Surgical Digestive Endoscopy, Civil Hospital of Avezzano, L’Aquila, Italy; ²³ Section of Gastroenterology and Digestive Endoscopy, Michele e Pietro Ferrero Hospital, Cuneo, Italy; ²⁴ Unit of Gastroenterology and Digestive Endoscopy, ASL Benevento, Benevento, Italy; ²⁵ U.O.S.D Gastroenterology, San Camillo de Lellis Civil Hospital, Rieti, Italy; ²⁶ Section of Gastroenterology, A.S.U. Giuliano Isontina, Trieste, Italy

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders. IBS is characterized by recurrent chronic abdominal pain and altered bowel habits in the absence of organic damage. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS presentation make treatment difficult. Treatment of IBS focuses on relieving symptoms as mild signs and symptoms can often be controlled by managing stress and by making changes in diet and lifestyle. The use of nutraceutical compounds has been advocated as a possible alternative treatment in patients with IBS. COLONIR^® (Omega Pharma Srl, Milan, Italy) may be an alternative or adjuvant treatment in patients with gastrointestinal symptoms. This study aimed to evaluate the effect of this new nutraceutical formulation in inducing symptoms remission and improve gastrointestinal habits.
METHODS: An initial cohort of 1004 consecutive patients referred to 25 different Units of Internal Medicine a/o Gastroenterology in Italy to perform colonoscopy for intestinal symptoms was asked to participate. Patients were treated for 2 months with three doses of nutraceuticals/day after meals namely COLONIR^®. Patients were assessed at baseline and after 2 months to evaluate the frequency and severity of gastrointestinal symptoms in the past seven days with a questionnaire based on ROMA IV criteria.
RESULTS: After 2 months, 899 patients completed the follow-up. COLONIR^® achieved a statistically significant reduction of severity of symptoms in the study population without any documented side effects.
CONCLUSIONS: These promising results, here reported, need to be confirmed, valuating the efficacy of COLONIR^® in relieving gastrointestinal symptoms in IBS patients in further studies.

KEY WORDS: Irritable bowel syndrome; Gastroenterology; Dietary supplements