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

NCT ID: NCT07065942

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-07-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactulose Oral Solution

Group Type: ACTIVE_COMPARATOR

Lactulose oral solution

Intervention Type: DRUG

Oral, 30 mL once daily administered during breakfast.

Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules

Group Type: EXPERIMENTAL

Lactulose oral solution

Intervention Type: DRUG

Oral, 30 mL once daily administered during breakfast.

Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules

Intervention Type: DRUG

Oral, 2 tablets (500 mg per tablet) three times daily (TID).

Interventions

Lactulose oral solution

Oral, 30 mL once daily administered during breakfast.

Intervention Type: DRUG

Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules

Oral, 2 tablets (500 mg per tablet) three times daily (TID).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Beijing Huaxin Hospital

UNKNOWN

Sponsor Role: collaborator

Beijing Luhe Hospital

OTHER

Sponsor Role: collaborator

Beijing Huairou Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing-Nan Li

Chief physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingnan Li, MD, Ph.D

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yaowen Hu

Role: CONTACT

1440556437@qq.com

+86 18811618952

Facility Contacts

Yaowen Hu

Role: primary

1440556437@qq.com

+86 18811618952

Other Identifiers

I-23PJ993

Identifier Type: -

Identifier Source: org_study_id