Constipation
Conditions
Interventions
Group A1 (H. pylori eradication without probiotics):Amoxicillin-clavulanate potassium tablets (1.0 g + 142.5 mg), t.i.d. + Vonoprazan fumarate tablets (20 mg), b.i.d. for 14 days.
Group A2 (H. pylori eradication + probiotics)::Amoxicillin-clavulanate potassium tablets (1.0 g + 142.5 mg), t.i.d. + Vonoprazan fumarate tablets (20 mg), b.i.d. for 14 days.
Compound Lactobacillus ac
Group B (Probiotics alone, no H. pylori eradication):Compound Lactobacillus acidophilus tablets (1 g, t.i.d.) for 42 days.
Group C (H. pylori-negative control):Compound Lactobacillus acidophilustablets (1 g, t.i.d.) for 42 days.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–75 years. 2. Functional constipation meeting Rome IV criteria: (1) >=2 of the following symptoms for >25% of defecations: straining, lumpy/hard stools, sensation of incomplete evacuation, anorectal obstruction/blockage, manual maneuvers to facilitate defecation, and =6 months, with active criteria fulfilled in the last 3 months. 3. For patients with concomitant H. pyloriinfection, the infection must be confirmed by a positive result from any one of the following tests: 13C- or 14C-urea breath test, rapid urease test, or gastric biopsy.
Exclusion criteria
Exclusion criteria: 1. Severe constipation (persistent symptoms severely affecting life, unresponsive to medication) or demand for alternative therapies (e.g., laxatives). 2. Comorbid peptic ulcer, organic colorectal/anorectal diseases, or history of abdominal/pelvic surgery. 3. Systemic diseases affecting gastrointestinal motility (e.g., neurological disorders, autoimmune diseases), major organ dysfunction (heart, liver, kidney), or psychiatric/cognitive impairments. 4. Recent use of antibiotics (within 4 weeks), acid suppressants (within 4 weeks), probiotics (within 2 weeks), or opioids. 5. Allergy or intolerance to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Spontaneous Bowel Movements (CSBMs); | — |
Secondary
| Measure | Time frame |
|---|---|
| CSBMs/SBMs;Bristol stoolscale;Time to first CSBM;Patient Assessment of Constipation Symptom (PAC-SYM) score;Laxative use proportion;Hp eradication rate; | — |
Countries
China
Contacts
Public ContactYurong Tang
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed