Efficacy of sodium butyrate in inducing remission in patients with mild-to-moderate ulcerative colitis

Efficacy of microencapsulated sodium butyrate as an add-on therapy in inducing remission in patients with mild-to-moderate ulcerative colitis: Results from a multi-center, double-blind, randomized, placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14915997

Enrollment

107

Registered

2025-02-06

Start date

2021-04-01

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapy for mild to moderate ulcerative colitis Digestive System

Interventions

The study include patients with mild-to-moderate ulcerative colitis, defined by a Total Mayo Score (TMS) between 3 and 10 points. Participants are aged 18 -65 years, with disease confirmed through end

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: 18–65 years. 2. Ulcerative colitis (UC) confirmed through endoscopic and histological examinations based on guidelines from the Polish Society of Gastroenterology and the European Crohn’s and Colitis Organisation at least one year before the study. 3. Mild-to-moderate ulcerative colitis (defined by a Total Mayo Score between 3-10 points).

Exclusion criteria

Exclusion criteria: 1. Age >65 years or <18 years 2. UC limited to the rectum (proctitis - E1 in the Montreal classification) 3. Recent escalation of treatment or addition of another therapy within 24 weeks before the study, 4. Use of antibiotics, pro-/pre-/synbiotics, SCFAs, or other supplements within 12 weeks before qualification and/or during the study 5. Significant changes in diet and lifestyle 6. Diagnosis of COVID-19 during or within 8 weeks before the study 7. Other gastrointestinal diseases 8. History of colostomy or cancer 9. Hospitalization during the study 10. Pregnancy or lactation. 11. Reluctance to participate.

Design outcomes

Primary

Measure	Time frame
1. Clinical improvement is measured using TMS reduction (= 3 points) at week 8 2. Clinical remission is measured using TMS (= 2), stool frequency subscore (= 1), rectal bleeding subscore (0), endoscopic subscore (= 1 without friability) at at week 8 3. Endoscopic improvement is measured using one-degree reduction in endoscopic score at at week 8 4. Endoscopic remission is measured using Mayo score (0) at at week 8 5. Biochemical remission is measured using fecal calprotectin (= 250 µg/g) at at week 8	—

Measure

Time frame

1. Clinical improvement is measured using TMS reduction (= 3 points) at week 8 2. Clinical remission is measured using TMS (= 2), stool frequency subscore (= 1), rectal bleeding subscore (0), endoscopic subscore (= 1 without friability) at at week 8 3. Endoscopic improvement is measured using one-degree reduction in endoscopic score at at week 8 4. Endoscopic remission is measured using Mayo score (0) at at week 8 5. Biochemical remission is measured using fecal calprotectin (= 250 µg/g) at at week 8

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Secondary

Measure	Time frame
1. Butyric acid (C4) concentration in stool is measured using mass spectrometry at 8 weeks after enrollment 2. Fecal calprotectin is measured using immunochemiluminescence technique at 8 weeks after enrollment 3. C-reactive protein is measured using immunoturbidimetry (IT) at 8 weeks after enrollment 4. Erythrocyte sedimentation rate (ESR) is measured using capillary photometric-kinetic technique at 8 weeks after enrollment 5. Hemoglobin (Hb) is measured using photometric method at 8 weeks after enrollment 6. Ferritin is measured using immunoturbidimetry (IT) at 8 weeks after enrollment 7. Albumin is measured using colorimetric measurements at 8 weeks after enrollment 8. Total protein is measured using colorimetric measurements at 8 weeks after enrollment 9. Vitamin D3 is measured using chemiluminescence technique at 8 weeks after enrollment	—

Measure

Time frame

1. Butyric acid (C4) concentration in stool is measured using mass spectrometry at 8 weeks after enrollment 2. Fecal calprotectin is measured using immunochemiluminescence technique at 8 weeks after enrollment 3. C-reactive protein is measured using immunoturbidimetry (IT) at 8 weeks after enrollment 4. Erythrocyte sedimentation rate (ESR) is measured using capillary photometric-kinetic technique at 8 weeks after enrollment 5. Hemoglobin (Hb) is measured using photometric method at 8 weeks after enrollment 6. Ferritin is measured using immunoturbidimetry (IT) at 8 weeks after enrollment 7. Albumin is measured using colorimetric measurements at 8 weeks after enrollment 8. Total protein is measured using colorimetric measurements at 8 weeks after enrollment 9. Vitamin D3 is measured using chemiluminescence technique at 8 weeks after enrollment

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Countries

Poland

Contacts

Public ContactKatarzyna Karlowicz

katarzyna.karlowicz@cskmswia.gov.pl+48 477221240

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026