MedTrace Logo

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

NCT07065942 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

Lactulose oral solution

Oral, 30 mL once daily administered during breakfast.

DRUG

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

Oral, 2 tablets (500 mg per tablet) three times daily (TID).

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • Beijing Huaxin Hospital

    collaborator UNKNOWN

  • Beijing Luhe Hospital

    collaborator OTHER

  • Beijing Huairou Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Jingnan Li, MD, Ph.D · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07065942 on ClinicalTrials.gov