A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD

Summary

The primary goals of this phase 2 clinical trial are to determine the feasibility, safety, and tolerability of oral Fecal Microbiota Transplantation (FMT) in adolescents (aged 13-17) with Attention-Deficit/Hyperactivity Disorder (ADHD).

Timeline

Start

2026-08-31

Primary completion

2028-08-31

Completion

2029-08-31

Publications

• Background Nanda A, Janga LSN, Sambe HG, Yasir M, Man RK, Gogikar A, Mohammed L. Adverse Effects of Stimulant Interventions for Attention Deficit Hyperactivity Disorder (ADHD): A Comprehensive Systematic Review. Cureus. 2023 Sep 26;15(9):e45995. doi: 10.7759/cureus.45995. eCollection 2023 Sep.
• Background Anand N, Gorantla VR, Chidambaram SB. The Role of Gut Dysbiosis in the Pathophysiology of Neuropsychiatric Disorders. Cells. 2022 Dec 23;12(1):54. doi: 10.3390/cells12010054.
• Background Prehn-Kristensen A, Zimmermann A, Tittmann L, Lieb W, Schreiber S, Baving L, Fischer A. Reduced microbiome alpha diversity in young patients with ADHD. PLoS One. 2018 Jul 12;13(7):e0200728. doi: 10.1371/journal.pone.0200728. eCollection 2018.
• Background Steckler R, Magzal F, Kokot M, Walkowiak J, Tamir S. Disrupted gut harmony in attention-deficit/hyperactivity disorder: Dysbiosis and decreased short-chain fatty acids. Brain Behav Immun Health. 2024 Jul 27;40:100829. doi: 10.1016/j.bbih.2024.100829. eCollection 2024 Oct.
• Background Yang LL, Stiernborg M, Skott E, Xu J, Wu Y, Landberg R, Arefin S, Kublickiene K, Millischer V, Nilsson IAK, Schalling M, Giacobini M, Lavebratt C. Effects of a Synbiotic on Plasma Immune Activity Markers and Short-Chain Fatty Acids in Children and Adults with ADHD-A Randomized Controlled Trial. Nutrients. 2023 Mar 6;15(5):1293. doi: 10.3390/nu15051293.
• Background Yang LL, Stiernborg M, Skott E, Gillberg T, Landberg R, Giacobini M, Lavebratt C. Lower plasma concentrations of short-chain fatty acids (SCFAs) in patients with ADHD. J Psychiatr Res. 2022 Dec;156:36-43. doi: 10.1016/j.jpsychires.2022.09.042. Epub 2022 Sep 28.
• Background Ma L, Chen YH, Chen H, Liu YY, Wang YX. The function of hypothalamus-pituitary-adrenal axis in children with ADHD. Brain Res. 2011 Jan 12;1368:159-62. doi: 10.1016/j.brainres.2010.10.045. Epub 2010 Nov 12.
• Background Cetin FH, Ucaryilmaz H, Ucar HN, Artac H, Guler HA, Duran SA, Kilinc K, Turkoglu S. Regulatory T cells in children with attention deficit hyperactivity disorder: A case-control study. J Neuroimmunol. 2022 Jun 15;367:577848. doi: 10.1016/j.jneuroim.2022.577848. Epub 2022 Mar 21.
• Background Ozyurt G, Ozturk Y, Appak YC, Arslan FD, Baran M, Karakoyun I, Tufan AE, Pekcanlar AA. Increased zonulin is associated with hyperactivity and social dysfunctions in children with attention deficit hyperactivity disorder. Compr Psychiatry. 2018 Nov;87:138-142. doi: 10.1016/j.comppsych.2018.10.006. Epub 2018 Oct 29.
• Background Lee SY, Li SC, Yang CY, Kuo HC, Chou WJ, Wang LJ. Gut Leakage Markers and Cognitive Functions in Patients with Attention-Deficit/Hyperactivity Disorder. Children (Basel). 2023 Mar 5;10(3):513. doi: 10.3390/children10030513.
• Background Aarts E, Ederveen THA, Naaijen J, Zwiers MP, Boekhorst J, Timmerman HM, Smeekens SP, Netea MG, Buitelaar JK, Franke B, van Hijum SAFT, Arias Vasquez A. Gut microbiome in ADHD and its relation to neural reward anticipation. PLoS One. 2017 Sep 1;12(9):e0183509. doi: 10.1371/journal.pone.0183509. eCollection 2017.
• Background Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
• Background Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.
• Background Zhang Y, Zhang J, Pan Z, He X. Effects of Washed Fecal Bacteria Transplantation in Sleep Quality, Stool Features and Autism Symptomatology: A Chinese Preliminary Observational Study. Neuropsychiatr Dis Treat. 2022 Jun 11;18:1165-1173. doi: 10.2147/NDT.S355233. eCollection 2022.
• Background Tengeler AC, Dam SA, Wiesmann M, Naaijen J, van Bodegom M, Belzer C, Dederen PJ, Verweij V, Franke B, Kozicz T, Arias Vasquez A, Kiliaan AJ. Gut microbiota from persons with attention-deficit/hyperactivity disorder affects the brain in mice. Microbiome. 2020 Apr 1;8(1):44. doi: 10.1186/s40168-020-00816-x.
• Background Harigai W, Mikami K, Choudhury ME, Yamauchi H, Yajima C, Shimizu S, Miyaue N, Nagai M, Kubo M, Tanaka J, Katayama T. Effects of fecal microbiota transplantation on behavioral abnormality in attention deficit hyperactivity disorder-like model rats. J Pharmacol Sci. 2025 Mar;157(3):189-198. doi: 10.1016/j.jphs.2025.01.007. Epub 2025 Jan 27.
• Background Hooi SL, Dwiyanto J, Rasiti H, Toh KY, Wong RKM, Lee JWJ. A case report of improvement on ADHD symptoms after fecal microbiota transplantation with gut microbiome profiling pre- and post-procedure. Curr Med Res Opin. 2022 Nov;38(11):1977-1982. doi: 10.1080/03007995.2022.2129232. Epub 2022 Oct 7.
• Background Li A, Costello SP, Bryant RV, Haylock-Jacobs S, Haifer C, Lee C, Yeung D, Giri P, Blunt D, Bowen JB, Ryan FJ, Yong A, Wardill HR. A study protocol for a double-blinded, randomised, placebo-controlled trial on the use of encapsulated FMT for reducing the side effects of HSCT: the HSCT-BIOME study. BMC Cancer. 2025 Apr 10;25(1):656. doi: 10.1186/s12885-025-14057-4.
• Background Staley C, Kaiser T, Vaughn BP, Graiziger C, Hamilton MJ, Kabage AJ, Khoruts A, Sadowsky MJ. Durable Long-Term Bacterial Engraftment following Encapsulated Fecal Microbiota Transplantation To Treat Clostridium difficile Infection. mBio. 2019 Jul 23;10(4):e01586-19. doi: 10.1128/mBio.01586-19.

Drugs

Indications