Sponsor study identifier
interventional
82
1 country
1
Study Start
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks. Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2024
Actual (reported)February 21, 2024
Actual (reported)September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Average Score on Visual Analog Scale for Abdominal Pain
Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms.
Baseline to 8 weeks post-treatment.
Improvement in Quality of Life with PedsQL 3.0
Baseline to 8 weeks post-treatment.
Improvement in Quality of Life with PedsQL 3.0
Baseline to 4 weeks post-treatment.
Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets, a single dose (night), for a period of 8 weeks.
Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.
Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
School of Medicine, University of Colima
Colima, 28040, Mexico
Korterink JJ, Diederen K, Benninga MA, Tabbers MM. Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis. PLoS One. 2015 May 20;10(5):e0126982. doi: 10.1371/journal.pone.0126982. eCollection 2015.
Simren M, Tornblom H, Palsson OS, Van Oudenhove L, Whitehead WE, Tack J. Cumulative Effects of Psychologic Distress, Visceral Hypersensitivity, and Abnormal Transit on Patient-reported Outcomes in Irritable Bowel Syndrome. Gastroenterology. 2019 Aug;157(2):391-402.e2. doi: 10.1053/j.gastro.2019.04.019. Epub 2019 Apr 22.
Pablo H Sandoval-Villaseñor, MD
Universidad de Colima
Fabián Rojas-Larios, PhD
Universidad de Colima
Carmen A Sánchez-Ramírez, PhD
Universidad de Colima
First Submitted
January 23, 2024
First Posted
February 21, 2024
Study Start
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Average Score on Visual Analog Scale for Abdominal Pain
Baseline to 4 weeks post-treatment.
Number of Participants with Treatment-Related Adverse Events
Baseline to 8 weeks post-treatment.
Participants received Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.
Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack I, Nurko S, Saps M, Shulman RJ, Szajewska H, van Tilburg MAL, Enck P. Paediatric functional abdominal pain disorders. Nat Rev Dis Primers. 2020 Nov 5;6(1):89. doi: 10.1038/s41572-020-00222-5.
Ding FCL, Karkhaneh M, Zorzela L, Jou H, Vohra S. Probiotics for paediatric functional abdominal pain disorders: A rapid review. Paediatr Child Health. 2019 Sep;24(6):383-394. doi: 10.1093/pch/pxz036. Epub 2019 May 4.
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Chumpitazi BP, Kearns GL, Shulman RJ. Review article: the physiological effects and safety of peppermint oil and its efficacy in irritable bowel syndrome and other functional disorders. Aliment Pharmacol Ther. 2018 Mar;47(6):738-752. doi: 10.1111/apt.14519. Epub 2018 Jan 26.
Karabulut GS, Beser OF, Erginoz E, Kutlu T, Cokugras FC, Erkan T. The Incidence of Irritable Bowel Syndrome in Children Using the Rome III Criteria and the Effect of Trimebutine Treatment. J Neurogastroenterol Motil. 2013 Jan;19(1):90-3. doi: 10.5056/jnm.2013.19.1.90. Epub 2013 Jan 8.
Wallace C, Gordon M, Sinopoulou V, Akobeng AK. Probiotics for management of functional abdominal pain disorders in children. Cochrane Database Syst Rev. 2023 Feb 17;2(2):CD012849. doi: 10.1002/14651858.CD012849.pub2.
Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
Khrizman M, Pakalnis A. Management of Pediatric Migraine: Current Therapies. Pediatr Ann. 2018 Feb 1;47(2):e55-e60. doi: 10.3928/19382359-20180129-02.
Saps M, Velasco-Benitez CA, Langshaw AH, Ramirez-Hernandez CR. Prevalence of Functional Gastrointestinal Disorders in Children and Adolescents: Comparison Between Rome III and Rome IV Criteria. J Pediatr. 2018 Aug;199:212-216. doi: 10.1016/j.jpeds.2018.03.037. Epub 2018 May 7.
Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24.
Chiou E, Nurko S. Management of functional abdominal pain and irritable bowel syndrome in children and adolescents. Expert Rev Gastroenterol Hepatol. 2010 Jun;4(3):293-304. doi: 10.1586/egh.10.28.
Koppen IJN, Saps M, Lavigne JV, Nurko S, Taminiau JAJM, Di Lorenzo C, Benninga MA. Recommendations for pharmacological clinical trials in children with functional constipation: The Rome foundation pediatric subcommittee on clinical trials. Neurogastroenterol Motil. 2018 Apr;30(4):e13294. doi: 10.1111/nmo.13294. Epub 2018 Jan 30.
Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211.
van Tilburg MA, Hyman PE, Walker L, Rouster A, Palsson OS, Kim SM, Whitehead WE. Prevalence of functional gastrointestinal disorders in infants and toddlers. J Pediatr. 2015 Mar;166(3):684-9. doi: 10.1016/j.jpeds.2014.11.039. Epub 2014 Dec 31.
Chumpitazi BP, Weidler EM, Lu DY, Tsai CM, Shulman RJ. Self-Perceived Food Intolerances Are Common and Associated with Clinical Severity in Childhood Irritable Bowel Syndrome. J Acad Nutr Diet. 2016 Sep;116(9):1458-1464. doi: 10.1016/j.jand.2016.04.017. Epub 2016 Jun 15.
Van Oudenhove L, Crowell MD, Drossman DA, Halpert AD, Keefer L, Lackner JM, Murphy TB, Naliboff BD, Levy RL. Biopsychosocial Aspects of Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00218-3. doi: 10.1053/j.gastro.2016.02.027. Online ahead of print.
Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
Newlove-Delgado TV, Martin AE, Abbott RA, Bethel A, Thompson-Coon J, Whear R, Logan S. Dietary interventions for recurrent abdominal pain in childhood. Cochrane Database Syst Rev. 2017 Mar 23;3(3):CD010972. doi: 10.1002/14651858.CD010972.pub2.
Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soffer EE, Spiegel BM, Moayyedi P. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol. 2014 Oct;109(10):1547-61; quiz 1546, 1562. doi: 10.1038/ajg.2014.202. Epub 2014 Jul 29.
Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.
Rutten JM, Reitsma JB, Vlieger AM, Benninga MA. Gut-directed hypnotherapy for functional abdominal pain or irritable bowel syndrome in children: a systematic review. Arch Dis Child. 2013 Apr;98(4):252-7. doi: 10.1136/archdischild-2012-302906. Epub 2012 Dec 6.
Palsson OS, Whitehead WE. Psychological treatments in functional gastrointestinal disorders: a primer for the gastroenterologist. Clin Gastroenterol Hepatol. 2013 Mar;11(3):208-16; quiz e22-3. doi: 10.1016/j.cgh.2012.10.031. Epub 2012 Oct 24.
Kountouras J, Gavalas E, Papaefthymiou A, Tsechelidis I, Polyzos SA, Bor S, Diculescu M, Jadallah Kappa, Tadeusz M, Karakan T, Bochenek Alpha, Rozciecha J, Dabrowski P, Sparchez Z, Sezgin O, Gulten M, Farsakh NA, Doulberis M. Trimebutine Maleate Monotherapy for Functional Dyspepsia: A Multicenter, Randomized, Double-Blind Placebo Controlled Prospective Trial. Medicina (Kaunas). 2020 Jul 8;56(7):339. doi: 10.3390/medicina56070339.
Vandenplas Y, Hauser B, Salvatore S. Functional Gastrointestinal Disorders in Infancy: Impact on the Health of the Infant and Family. Pediatr Gastroenterol Hepatol Nutr. 2019 May;22(3):207-216. doi: 10.5223/pghn.2019.22.3.207. Epub 2019 Apr 16.
Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.
Dryl R, Szajewska H. Probiotics for management of infantile colic: a systematic review of randomized controlled trials. Arch Med Sci. 2018 Aug;14(5):1137-1143. doi: 10.5114/aoms.2017.66055. Epub 2017 Feb 16.
Francavilla R, Miniello V, Magista AM, De Canio A, Bucci N, Gagliardi F, Lionetti E, Castellaneta S, Polimeno L, Peccarisi L, Indrio F, Cavallo L. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010 Dec;126(6):e1445-52. doi: 10.1542/peds.2010-0467. Epub 2010 Nov 15.
Romano C, Ferrau' V, Cavataio F, Iacono G, Spina M, Lionetti E, Comisi F, Famiani A, Comito D. Lactobacillus reuteri in children with functional abdominal pain (FAP). J Paediatr Child Health. 2014 Oct;50(10):E68-71. doi: 10.1111/j.1440-1754.2010.01797.x. Epub 2010 Jul 8.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 16, 2024
Record last verified: 2024-08
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