Diabetes MellitusNCT07065942
Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
A study testing Lactulose oral solution and Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules in people with Diabetes Mellitus and Constipation - Functional, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Constipation - Functional
- What is being tested?
- Lactulose oral solution and Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- ≥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
Who cannot join
- 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
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- Cerebrovascular diseases
- Psychiatric disorders
- Recent use (within 1 month) of confounding medications:
- Probiotics/prebiotics
- Antibiotics
- Laxatives (e.g., osmotic/stimulant agents)
- Prokinetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Yaowen Hu, +86 18811618952, 1440556437@qq.com
About this study
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
- Diabetes Mellitus, Constipation - Functional
- Being tested
- Lactulose oral solution, Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules
- Keywords
- Diabetes, Constipation, Lactulose, Gut Microbiota, Metabolism
- Medical subject headings
- Diabetes Mellitus, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose oral solutionDrug
Oral, 30 mL once daily administered during breakfast.
Live Combined B. Subtilis and E. Faecium Enteric-coated CapsulesDrug
Oral, 2 tablets (500 mg per tablet) three times daily (TID).
| Study group | Role | What they receive |
|---|---|---|
| Lactulose Oral Solution | Active comparator | Not described Receives: Drug: Lactulose oral solution |
| Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules | Experimental | Not described Receives: Drug: Lactulose oral solution; Drug: Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Constipation Symptom Scores Pre- and Post-Treatment
Assessment of treatment efficacy on constipation symptoms: Changes in symptom scores from baseline to post-treatment within each treatment arm and comparative analysis between the lactulose monotherapy group and lactulose+Medilac-S combination therapy group
Measured: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
Changes in Fecal Microbiota Composition (16S rRNA and Metagenomics)
Comparison of Fecal Microbiota Composition Changes (16S rRNA and Metagenomics): Pre- vs. Post-Treatment Alterations and Intergroup Differences Between Lactulose Monotherapy and Lactulose+Medilac-S Combination Therapy
Measured: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
Temporal Changes in Fecal Untargeted Metabolomics Profiles
Temporal Changes in Fecal Untargeted Metabolomics Profiles: Pre- vs. post-treatment alterations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination groups.
Measured: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
Secondary outcomes (2)
Changes in Fasting Blood Glucose and Glycated Albumin Levels
Changes in Fasting Blood Glucose and Glycated Albumin Levels: Pre- vs. post-treatment variations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination groups
Measured: 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)
Changes in Blood Lipid Profiles (Total Cholesterol, Triglycerides, HDL-C, and LDL-C): Pre- vs. post-treatment alterations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination therapy groups
Measured: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jul 2023
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Beijing Huaxin Hospital, Beijing Luhe Hospital, Beijing Huairou Hospital
- Responsible party
- Principal investigator, Jing-Nan Li, Peking Union Medical College Hospital
- Investigators
- Jingnan Li, MD, Ph.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065942
- Sponsor's protocol ID
- I-23PJ993
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
- ClinicalTrials.gov ID
- NCT07065942
- Acronym / sponsor ID
- I-23PJ993
- Conditions
- Diabetes Mellitus, Constipation - Functional
- Keywords
- Diabetes, Constipation, Lactulose, Gut Microbiota, Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Beijing Huaxin Hospital, Beijing Luhe Hospital, Beijing Huairou Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose Oral Solution | Active comparator | Drug: Lactulose oral solution |
| Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules | Experimental | Drug: Lactulose oral solution, Drug: Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: 18-70 years
- Type 2 Diabetes Diagnosis (per 2017 ADA criteria), meeting ≥1 of:
- Functional Constipation (Rome IV criteria), requiring:
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose oral solutionOral, 30 mL once daily administered during breakfast. | Drug | Lactulose Oral Solution, Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules |
| Live Combined B. Subtilis and E. Faecium Enteric-coated CapsulesOral, 2 tablets (500 mg per tablet) three times daily (TID). | Drug | Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules |
Primary outcome
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
Assessment of treatment efficacy on constipation symptoms: Changes in symptom scores from baseline to post-treatment within each treatment arm and comparative analysis between the lactulose monotherapy group and lactulose+Medilac-S combination therapy group
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
Comparison of Fecal Microbiota Composition Changes (16S rRNA and Metagenomics): Pre- vs. Post-Treatment Alterations and Intergroup Differences Between Lactulose Monotherapy and Lactulose+Medilac-S Combination Therapy
Temporal Changes in Fecal Untargeted Metabolomics Profiles
Time frame: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
Temporal Changes in Fecal Untargeted Metabolomics Profiles: Pre- vs. post-treatment alterations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination groups.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingnan Li, MD, Ph.D study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose oral solution and Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules in people with Diabetes Mellitus and Constipation - Functional, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaowen Hu (+86 18811618952, 1440556437@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.