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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yaowen Hu
• Email: 1440556437@qq.com
• Phone: +86 18811618952

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.