Lactulose with or without a probiotic for constipation in adults with type 2 diabetes

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

This project will try lactulose, alone or combined with a probiotic, to see if it helps constipation and changes gut bacteria in adults with type 2 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07065942 on ClinicalTrials.gov

What this trial studies

Adults with type 2 diabetes and functional constipation will receive lactulose oral solution and a live B. subtilis and E. faecium enteric-coated probiotic as part of the protocol. Researchers will collect stool and clinical data to track bowel habits, gut microbiota composition, and metabolic markers over the treatment period. The protocol emphasizes stable glycemic control and dietary stability to limit confounding influences on microbiota and bowel function. Outcomes will focus on symptom improvement, changes in microbial populations, and related metabolic pathway signals.

Who should consider this trial

Good fit: Adults aged 18–70 with type 2 diabetes (per 2017 ADA criteria) who meet Rome IV criteria for functional constipation and can maintain stable diabetes medications and diet are ideal candidates.

Not a fit: People with nonfunctional causes of constipation, a diagnosis of IBS, or unstable glycemic control that requires medication changes are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the interventions could improve constipation symptoms and restore healthier gut microbiota patterns in people with type 2 diabetes.

How similar studies have performed: Lactulose and prebiotic approaches have improved constipation and altered microbiota in other populations, but their specific effects in diabetic constipation are not well established.

Eligibility criteria

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 tolerance test (OGTT)
  3. Random plasma glucose ≥11.1 mmol/L with hyperglycemia symptoms or hyperglycemic crisis
* Functional Constipation (Rome IV criteria), requiring:

  1. ≥2 of the following

     1. occurring in ≥25% of defecations
     2. Straining
     3. Lumpy/hard stools (Bristol Stool Scale 1-2)
     4. Sensation of incomplete evacuation
     5. Anorectal obstruction/blockage
     6. Manual maneuvers required
     7. \<3 spontaneous bowel movements/week
  2. No loose stools without laxatives
  3. 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:

  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

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yaowen Hu

Conditions: Diabetes Mellitus, Constipation - Functional, Diabetes, Constipation, Lactulose, Gut Microbiota, Metabolism