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Clinical efficacy of Lactobacillus rhamnosus combined with lactulose in the treatment of irritable bowel syndrome with constipated and its effect on gastrointestinal hormones

Clinical efficacy of Lactobacillus rhamnosus combined with lactulose in the treatment of irritable bowel syndrome with constipated and its effect on gastrointestinal hormones

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123361
Enrollment
Unknown
Registered
2026-04-25
Start date
2022-01-08
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipated irritable bowel syndrome

Interventions

Control group:Patients were administered Mosapride Citrate Tablets (Chengdu Kanghong Pharmaceutical Group Co., Ltd., National Drug Approval No. H20031110, 5 mg/tablet), 3 times daily, 1 tablet each ti
Monotherapy group:In addition to the basic regimen of the control group, patients received lactulose oral solution (66.7 g/100 mL, manufactured by Dumex, Abbott Healthcare, USA), at a dosage of 10 mL,
Combination group:In addition to the regimen of the monotherapy group (basic treatment + lactulose), patients received Lactobacillus rhamnosus GG (LGG) powder (Jingchangle, produced by Zhejiang Jingxi
containing >=1.0×10^9 CFU/g of viable bacteria) at a dosage of 500 mg, three times daily.

Sponsors

Taishan Hospital of Shandong Province
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: According to the 2006 Rome ? criteria, abdominal pain, abdominal distension and abdominal discomfort had been present for at least 6 months and recurred in the past 3 months, and at least 2 of the following symptoms had been present for at least 3 days per month in the past 3 months: 1. Symptoms improved after defecation. 2. Seizures accompanied by changes in defecation frequency; 3. Defecation less than 3 times per week; 4. Lumpy stool/hard stool; 5. Feeling of incomplete defecation; 6. Bloating.

Exclusion criteria

Exclusion criteria: 1. Intestinal organic diseases such as intestinal cancer, intestinal tuberculosis and ulcerative colitis; 2. Endocrine, drug-induced and neurogenic constipation; 3. No laxatives were used 3 months before treatment, which affected gastrointestinal motility drugs, digestive enzymes, and probiotics preparations.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy;

Secondary

MeasureTime frame
Bristol Bowel Scale;Irritable bowel syndrome Quality of life score;Perceived Stress Scale;Irritable bowel syndrome severity scoring system;Gut microbiota;Gastrointestinal hormones;Safety observation;

Countries

China

Contacts

Public ContactWu Rongfang

Taishan Hospital of Shandong Province

wurongfang2060@163.com+86 137 9211 8256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026