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Recruiting NCT07065942

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

No phase Interventional Diabetes Mellitus Constipation - Functional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactulose oral solution, Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Constipation - Functional. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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).

Primary outcome measures

  • Changes in Constipation Symptom Scores Pre- and Post-Treatment [Time frame: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment]
  • Changes in Fecal Microbiota Composition (16S rRNA and Metagenomics) [Time frame: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment]
  • Temporal Changes in Fecal Untargeted Metabolomics Profiles [Time frame: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment]
Secondary outcome measures (2)
  • Changes in Fasting Blood Glucose and Glycated Albumin Levels [Time frame: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment]
  • Changes in Blood Lipid Profiles (Total Cholesterol, Triglycerides, HDL-C, and LDL-C) [Time frame: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment]

Eligibility criteria

Inclusion criteria

  • Age: 18-70 years
  • Type 2 Diabetes Diagnosis (per 2017 ADA criteria), meeting ≥1 of:
  • Fasting plasma glucose (FPG) ≥7.0 mmol/L
  • hour plasma glucose ≥11.1 mmol/L during 75g anhydrous oral glucose tolerance test (OGTT)
  • Random plasma glucose ≥11.1 mmol/L with hyperglycemia symptoms or hyperglycemic crisis
  • Functional Constipation (Rome IV criteria), requiring:
  • ≥2 of the following
  • occurring in ≥25% of defecations
  • Straining
  • Lumpy/hard stools (Bristol Stool Scale 1-2)
  • Sensation of incomplete evacuation
  • Anorectal obstruction/blockage
  • Manual maneuvers required
  • <3 spontaneous bowel movements/week
  • No loose stools without laxatives
  • Exclusion of IBS diagnosis. Symptom duration >6 months, with active symptoms meeting criteria for last 3 months.
  • Stable Glycemic Control: No anticipated antidiabetic medication adjustments during study
  • Dietary Stability: Maintain consistent diet; avoid yogurt, fermented foods, prebiotic-containing processed foods, or other items that may confound results

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, colorectal cancer).
  • Type 1 Diabetes Mellitus.
  • Severe chronic comorbidities, including:
  • Cardiopulmonary insufficiency
  • Cerebrovascular diseases
  • Psychiatric disorders
  • Recent use (within 1 month) of confounding medications:
  • Probiotics/prebiotics
  • Antibiotics
  • Laxatives (e.g., osmotic/stimulant agents)
  • Prokinetics

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07065942 · I-23PJ993

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗