NSAIDs Enteropathy
Conditions
Interventions
Teprenone Group: Participants will take50 mg of Teprenone capsules once after breakfast, once after lunch, and once after dinner, for a total of8 weeks
Teprenone + Probiotics Group: Participants will take50 mg of Teprenone capsules and1 g of compound Lactobacillus acidophilus tablets once after breakfast, once after lunch, and once after dinner, for
Control Group: Participants will take1 g of aluminum magnesium carbonate once after breakfast, once after lunch, and once after dinner, for a total of8 weeks
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged18 to70 years, both males and females. 2. Have taken NSAIDs at least once daily for the past4 weeks prior to the start of the study and have exhibited symptoms or signs of abdominal discomfort, such as abdominal pain, bloating, or dyspepsia. 3. Confirmed small intestinal mucosal injury via capsule endoscopy. 4. Agree to continue using NSAIDs after enrollment. 5. Voluntarily agree to participate in this clinical trial and willing to sign the informed consent form. 6. Subjects (including male subjects) agree to refrain from pregnancy from the screening date until3 months after the last administration of the investigational drug and voluntarily commit to using effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Active gastrointestinal bleeding (with hematemesis or melena and progressively decreasing HGB). 2. Patients taking two or more NSAIDs, anticoagulants, or unable to discontinue proton pump inhibitors, H2 receptor antagonists, potassium-competitive acid blockers, steroids, prostaglandin derivatives, or other mucosal protectants during the study period. 3. History of gastric or duodenal ulcers, gastrointestinal tumors, or other malignancies; or suspected small intestinal mucosal injury due to other causes (e.g., Crohn's disease of the small intestine, chemotherapy drugs, or immunosuppressive agents) or suspected risk of intestinal obstruction. 4. History of gastrointestinal surgery, except for appendectomy. 5. Severe cardiovascular or pulmonary diseases (NYHA class IV heart failure or respiratory failure). 6. Significant renal impairment (serum creatinine >=2 mg/dL or estimated glomerular filtration rate (eGFR) 2.0 ULN, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) >=2.0 ULN). 8. Alcohol intake >50 g/day. 9. Pregnant or breastfeeding women. 10. Participation in other drug trials within the past 3 months, or currently participating in other studies. 11. Subjects deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of small intestinal mucosal injuries (erosions, ulcers, and strictures) at week8; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes of Lewis score of small intestinal mucosal injury at week0,8;changes in gastrointestinal symptom scores at weeks0,4, and8;changes in fecal calprotectin at weeks0,4, and8;changes in fecal microbiota and serum and fecal metabolites at weeks0,4, and8; | — |
Countries
China
Contacts
Public ContactJingnan Li
Peking Union Medical College Hospital
Outcome results
None listed