18 completed, 4 recruiting, 2 not yet recruiting, 1 active not recruiting. 20 Not applicable, 6 Phase 2, 2 Phase 1, 1 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity), Butyrate, Intensive lifestyle modification + butyrate - Type 1 Diabetes | Not applicable | Not yet recruiting | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | 200 | 2026-09-15 | 2026-07-06 |
| Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients Butyrate and Taurine, Placebo - Pain, Acute, Pain, Chronic | Not applicable | Recruiting | Chinese University of Hong Kong | 216 | 2026-06-20 | 2026-10-22 |
| Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Butyrate - Ulcerative Colitis (Disorder) | Not applicable | Recruiting | University of Padova | 40 | 2026-05-01 | 2026-05-15 |
| A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients PLL001 or placebo daily subcutaneous injections - Amyotrophic Lateral Sclerosis, ALS | Phase 1 / Phase 2 | Not yet recruiting | PLL TX AUSTRALIA PTY LTD | 153 | 2026-04-08 | 2026-03-19 |
| Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders Cardiovascular Exercise, Butyrate - Obesity &Amp; Overweight | Not applicable | Active not recruiting | Texas Christian University | 40 | 2026-01-18 | 2026-09-29 |
| A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms Butyrate + Polyphenol Formulation, Placebo - Gut Health | Not applicable | Completed | Supplement Formulators, Inc. | 124 | 2025-10-16 | 2026-08-26 |
| Pharmacokinetics of Butyrate Tablet BKR-017 BKR-017 - Hypercholesterolemia | Completed | BioKier Inc. | 9 | 2025-07-16 | 2026-06-09 | |
| Dietary Supplements to Treat Radiation-Induced Rectal Injury Butyrate - Radiotherapy, Radiation Proctitis | Phase 2 | Recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | 33 | 2025-01-15 | 2026-08-07 |
| Butyrate-enriched Triglyceride and Diabetes Prevention butyrate/hexanoate-enriched triglycerides - Type 2 Diabetes, PreDiabetes | Not applicable | Completed | Maastricht University Medical Center | 44 | 2024-09-19 | 2026-10-28 |
| Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission Hydroxocobalamin with Butyrate, Placebo with Butyrate - Ulcerative Colitis | Phase 2 | Withdrawn | Joshua Korzenik | 2024-01-01 | 2024-04-22 | |
| Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms Butyrate Formulation, Butyrate + Polyphenol Formulation, Placebo - Gut Health | Not applicable | Completed | Supplement Formulators, Inc. | 143 | 2023-10-31 | 2026-01-13 |
| Effect of Short-chain Fatty Acids on Aerobic Endurance High-amylose maize starch+acetate/butyrate, Low-amylose maize starch - Aerobic Endurance, Metabolism | Not applicable | Completed | United States Army Research Institute of Environmental Medicine | 21 | 2023-07-21 | 2025-12-26 |
| Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders Butyrate - Rheumatoid Arthritis | Not applicable | Completed | NYU Langone Health | 20 | 2023-02-01 | 2026-09-02 |
| Butyrate Adjuvant Therapy for Type 1 Diabetes BKR-017 - Type1diabetes | Phase 1 / Phase 2 | Completed | Mayo Clinic | 6 | 2022-07-28 | 2026-03-31 |
| The Use of Butyrate Therapy in Pediatric Ulcerative Colitis Butyrate - Ulcerative Colitis | Phase 2 | Recruiting | Children's Hospital Los Angeles | 10 | 2022-06-29 | 2026-06-04 |
| A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA) Short Chain Fatty Acids (SCFA) Dietary Supplement - Rheumatoid Arthritis | Not applicable | Completed | NYU Langone Health | 24 | 2021-11-17 | 2024-06-24 |
| Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients BKR-017 - Type 2 Diabetes | Not applicable | Completed | BioKier Inc. | 60 | 2021-04-18 | 2023-02-08 |
| Effects of Butyrate on Affective Processes Placebo, Butyrate - Emotions, Stress | Not applicable | Completed | KU Leuven | 72 | 2021-02-08 | 2023-01-04 |
| Butyrate/Hexanoate in Metabolic Health Placebo, butyrate and hexanoate amount 1, butyrate and hexanoate amount 2 - Metabolic Disease | Not applicable | Completed | Maastricht University Medical Center | 14 | 2021-01-13 | 2021-11-29 |
| Effects of Butyrate Against Pediatric Obesity butyrate, placebo - Obesity, Childhood | Not applicable | Completed | Federico II University | 54 | 2020-11-01 | 2022-04-08 |
Showing 20 of 27. Sign in to see all of them.
Obesity (4) · Colitis, Ulcerative (3) · Diabetes Mellitus, Type 2 (3) · Abdominal Pain (2) · Arthritis, Rheumatoid (2) · Behcet Syndrome (2) · Constipation (2) · Diarrhea (2) · Inflammatory Bowel Diseases (2) · Insulin Resistance (2) · Mucopolysaccharidosis IV (2) · Acute Pain (1) · Amyotrophic Lateral Sclerosis (1) · Chronic Pain (1) · Diabetes Mellitus, Type 1 (1)
Maastricht University Medical Center (4) · Azienda Ospedaliero-Universitaria Careggi (2) · BioKier Inc. (2) · Federico II University (2) · NYU Langone Health (2) · Supplement Formulators, Inc. (2) · University of Padova (2) · Children's Hospital Los Angeles (1) · Chinese University of Hong Kong (1) · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (1) · Joshua Korzenik (1) · KU Leuven (1) · Mayo Clinic (1) · PLL TX AUSTRALIA PTY LTD (1) · Sixth Affiliated Hospital, Sun Yat-sen University (1)
United States (11) · Italy (6) · Netherlands (4) · Belgium (1) · Canada (1) · China (1) · Hong Kong (1) · Spain (1)
Jose Scher, MD (2) · Adrian Vella, MD (1) · Alessandro Casini, MD (1) · Andrew Swick, Ph.D (1) · Andrew Swick, PhD (1) · Edoardo V Savarino (1) · Edoardo V. Savarino, Prof. MD, PhD (1) · Frank Greenway, MD (1) · Henry Wong, MBChB (1) · J. Philip Karl, PhD (1) · Joshua R Korzenik, MD (1) · Kristin Verbeke, Prof (1) · Rebecca B Blank, MD, PhD (1) · Robert-Jan Brummer, Prof (1) · Sonia Michail, MD (1)
PMID 32476236, PMID 32517729, PMID 36469320, PMID 36687671, PMID 41354580
R43HL174321 (1)