Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients

Last updated: July 4, 2025
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Constipation

Treatment

Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules

Lactulose oral solution

Clinical Study ID

NCT07065942
I-23PJ993
  • Ages 18-70
  • All Genders

Study Summary

Constipation is the most common gastrointestinal manifestation in diabetic patients. Emerging evidence suggests that gut microbiota dysbiosis may contribute to the pathogenesis of diabetes, highlighting the need to investigate its role in diabetic constipation, though current research remains limited.

Current management of diabetic constipation primarily relies on bulk-forming and osmotic laxatives. Additionally, microbiome-modulating agents (e.g., probiotics, prebiotics, and synbiotics) may serve as adjunctive therapies by regulating gut microbiota and enhancing intestinal motility. Lactulose, a well-tolerated osmotic laxative with prebiotic effects, is widely recommended in clinical guidelines. It promotes short-chain fatty acid production, increases fecal volume, and accelerates colonic transit, thereby alleviating constipation. However, its specific impact on gut microbiota composition and metabolic pathways in diabetic constipation remains unclear.

This study aims to explore changes in fecal microbiota and metabolomic profiles in diabetic patients with chronic constipation following treatment with lactulose alone or in combination with Bacillus subtilis-Enterococcus faecium probiotics, providing mechanistic insights into prebiotic therapy for this condition.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-70 years

  • Type 2 Diabetes Diagnosis (per 2017 ADA criteria), meeting ≥1 of:

  1. Fasting plasma glucose (FPG) ≥7.0 mmol/L

  2. hour plasma glucose ≥11.1 mmol/L during 75g anhydrous oral glucose tolerancetest (OGTT)

  3. Random plasma glucose ≥11.1 mmol/L with hyperglycemia symptoms or hyperglycemiccrisis

  • Functional Constipation (Rome IV criteria), requiring:

  1. ≥2 of the following

  2. occurring in ≥25% of defecations

  3. Straining

  4. Lumpy/hard stools (Bristol Stool Scale 1-2)

  5. Sensation of incomplete evacuation

  6. Anorectal obstruction/blockage

  7. Manual maneuvers required

  8. <3 spontaneous bowel movements/week

  9. No loose stools without laxatives

  10. Exclusion of IBS diagnosis. Symptom duration >6 months, with active symptomsmeeting criteria for last 3 months.

  • Stable Glycemic Control: No anticipated antidiabetic medication adjustments duringstudy

  • Dietary Stability: Maintain consistent diet; avoid yogurt, fermented foods,prebiotic-containing processed foods, or other items that may confound results

Exclusion

Exclusion Criteria:

  • Secondary Constipation due to organic diseases or medication effects.

  • Constipation-predominant Irritable Bowel Syndrome (IBS-C).

  • Concurrent gastrointestinal disorders (e.g., inflammatory bowel disease, colorectalcancer).

  • Type 1 Diabetes Mellitus.

  • Severe chronic comorbidities, including:

  1. Cardiopulmonary insufficiency

  2. Cerebrovascular diseases

  3. Psychiatric disorders

  • Recent use (within 1 month) of confounding medications:

  1. Probiotics/prebiotics

  2. Antibiotics

  3. Laxatives (e.g., osmotic/stimulant agents)

  4. Prokinetics

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
July 30, 2026

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

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