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New treatment option for Diabetes Mellitus
Official title Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
ClinicalTrials.gov ID: NCT07065942
What this study is testing
What is Lactulose oral solution?
Lactulose oral solution is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.