Clinical Trials

Numerous clinical trials evaluate sodium butyrate across a range of gastrointestinal, psychiatric, neurodevelopmental, and cardiovascular conditions, including shigellosis, schizophrenia, autism spectrum disorder, and hypertension. Spanning Phase 1 through Phase 3 evaluations as well as non-phase proof-of-concept studies, these protocols encompass completed, actively recruiting, and withdrawn statuses. Sponsorship is primarily driven by academic medical centers, international research organizations, and commercial entities.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07611370 NOT_YET_RECRUITING
Graft Versus Host Disease; Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm
City of Hope Medical Center
 2026-09-30 PHASE1
NCT07591012 RECRUITING
Ulcerative Colitis (Disorder)
University of Padova
 2026-05-01
NCT06653426 RECRUITING
Menstrual Symptoms
Magdy Milad, MD
 2024-10-01
NCT06514573 RECRUITING
Autism Spectrum Disorder (ASD)
Istituto Superiore di Sanità
 2025-05
NCT06851039 COMPLETED
Healthy
Wroclaw Medical University
 2025-03-06
NCT07252609 COMPLETED
Obesity; Type 2 Diabetes
Federico II University
 2024-11-13
NCT06448663 UNKNOWN
CDKL5
University of Milan
 2024-04-01
NCT06759363 UNKNOWN
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
University Medical Center Zvezdara
 2024-01-04 PHASE3
NCT06700785 COMPLETED
Gastro-Intestinal Disorder
The Center for Applied Health Sciences, LLC
 2024-05-03
NCT05576597 COMPLETED
Rheumatoid Arthritis
Peking University People's Hospital
 2022-08-23 PHASE2
NCT05013060 COMPLETED
Irritable Bowel Syndrome
Nordic Biotic Sp. z o.o.
 2021-04-15
NCT05808985 UNKNOWN
Graft Versus Host Disease; Postbiotics; Butyrate
Soonchunhyang University Hospital
 2022-09-02 PHASE2
NCT06247020 COMPLETED
Glucose Metabolism Disorders; Overweight or Obesity
Federico II University
 2022-02-24
NCT05420805 COMPLETED
Rett Syndrome; Dysbiosis; Epilepsy; Quality of Life
Azienda Ospedaliera Universitaria Senese
 2022-04-01
NCT04415333 COMPLETED
Hypertension
University of North Carolina, Chapel Hill
 2021-07-08 PHASE1
NCT06022588 COMPLETED
Chronic Mesenteric Ischemia
Erasmus Medical Center
 2021-03-01
NCT05249023 COMPLETED
Irritable Bowel Syndrome (IBS); Healthy
Örebro University, Sweden
 2018-04-11
NCT04073927 UNKNOWN
Diabetes Mellitus, Type 1; Albuminuria
Steno Diabetes Center Copenhagen
 2019-08-05
NCT03010865 WITHDRAWN
Schizophrenic Disorder; Cognitive Impairment
Shanghai Mental Health Center
 2017-06-01 PHASE2; PHASE3
NCT02654405 WITHDRAWN
Schizophrenic Disorders; Cognitive Function
Nathan Kline Institute for Psychiatric Research
 2016-04 PHASE2; PHASE3
NCT05456763 COMPLETED
Inflammatory Bowel Diseases
Centre of Postgraduate Medical Education
 2013-06
NCT02271802 COMPLETED
SCFA Metabolism
Maastricht University Medical Center
 2009-06
NCT00696098 COMPLETED
Gut Health
Maastricht University Medical Center
 2007-05
NCT00800930 COMPLETED
Shigellosis
International Centre for Diarrhoeal Disease Research, Bangladesh
 2005-01 PHASE2
NCT00693355 COMPLETED
Healthy
Maastricht University Medical Center
 2005-12
NCT00800930 Completed
Shigellosis
International Centre for Diarrhoeal Disease Research Bangladesh|Swedish International Development Cooperation Agency (SIDA)|Karolinska Institutet
 2005-01 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-05-28)

Check the Sodium butyrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium butyrate competitively binds to the zinc catalytic sites of class I and class II histone deacetylases (HDACs), inhibiting HDAC activity to induce widespread histone hyperacetylation and alter downstream gene expression. This enzymatic blockade suppresses cell cycle progression, promotes cell differentiation, and triggers apoptosis, providing a cellular mechanism for its therapeutic evaluation in clinical conditions such as shigellosis, irritable bowel syndrome, and neurological disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.