The effect of sodium butyrate on abdominal symptoms and carbohydrate metabolism in patients with type 2 diabetes

The effect of microencapsulated sodium butyrate on abdominal symptoms and carbohydrate metabolism in patients with type 2 diabetes: a randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10844715

Enrollment

Registered

2025-01-31

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Treatment of gastrointestinal symptoms and improvement of carbohydrate metabolism in patients with type 2 diabetes. Nutritional, Metabolic, Endocrine

Interventions

The study will include patients with type 2 diabetes who meet the Rome IV criteria for the diagnosis of irritable bowel syndrome (IBS). Participants will be randomized, using an application, into two

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: 18–80 years. 2. Diagnosed type 2 diabetes with no modifications to treatment for at least 3 months. 3. Meeting the Rome IV criteria for the diagnosis of irritable bowel syndrome (IBS).

Exclusion criteria

Exclusion criteria: 1. Age > 80 years or <18 2. Any changes in treatment within 3 months before qualification and/or during the study 3. Dietary interventions 4 weeks before qualification and/or during the study 4. Use of antibiotics 4 weeks before qualification and/or during the study 5. Use of prokinetics, antidiarrheal drugs, probiotics, sodium butyrate, proton pump inhibitors or H2 receptor blockers 14 days before qualification and/or during the study 6. Pregnancy or breastfeeding 7. Lactulose intolerance 8. Diagnosis of galactosemia

Design outcomes

Primary

Measure	Time frame
1. Changes in carbohydrate metabolism will be measured by assessing glycated hemoglobin (HbA1c) levels and calculating the HOMA-IR index at the start of the study and after the 12-week intervention. 2. Changes in the severity of gastrointestinal symptoms will be evaluated using a gastrointestinal symptom severity questionnaire, completed by participants at the start of the study and after the 12-week intervention.	—

Measure

Time frame

1. Changes in carbohydrate metabolism will be measured by assessing glycated hemoglobin (HbA1c) levels and calculating the HOMA-IR index at the start of the study and after the 12-week intervention. 2. Changes in the severity of gastrointestinal symptoms will be evaluated using a gastrointestinal symptom severity questionnaire, completed by participants at the start of the study and after the 12-week intervention.

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Secondary

Measure	Time frame
1. The presence of small intestinal bacterial overgrowth (SIBO) in patients will be assessed through a hydrogen breath test conducted at the start of the study and after the 12-week intervention 2. Fasting insulin levels in the blood of participants were measured using venous blood samples at the beginning of the study and after the 12-week intervention 3. Fasting glucose levels in the blood of participants were measured using venous blood samples at the beginning of the study and after the 12-week intervention	—

Measure

Time frame

1. The presence of small intestinal bacterial overgrowth (SIBO) in patients will be assessed through a hydrogen breath test conducted at the start of the study and after the 12-week intervention 2. Fasting insulin levels in the blood of participants were measured using venous blood samples at the beginning of the study and after the 12-week intervention 3. Fasting glucose levels in the blood of participants were measured using venous blood samples at the beginning of the study and after the 12-week intervention

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Countries

Poland

Contacts

Public ContactPaulina Panufnik

paulina.panufnik@cskmswia.gov.pl+48477221240

Outcome results

None listed

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