Status:
UNKNOWN
Efficacy and Safety of Dietary Supplementation of Diamine Oxidase to Improve Symptoms in Patients With IBS
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This project is a single center, randomized, controlled clinical trial evaluating the effects of DAO enzyme dietary supplement on symptoms of irritable bowel syndrome. These participants are randomiz...
Eligibility Criteria
Inclusion
- Age 18-65 years old;
- Diagnosed with IBS according to Rome IV diagnostic criteria; Recurrent abdominal pain occurred on an average of at least 1 day per week in the past 3 months and was associated with two or more of the following criteria: i. Related to defecation; ii. Associated with changes in bowel frequency; iii. Correlated with fecal morphological changes. The symptoms appeared at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months.
- Voluntarily participate in the experiment and sign the informed consent.
Exclusion
- Patients with endoscopy examinations which suggest chronic intestinal diseases other than IBS, such as inflammatory bowel disease, celiac disease, gastric and duodenal ulcers, parasitic or bacterial intestinal infections;
- Pregnant and lactating women;
- Patients suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease, tumor;
- Alcoholism.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06139744
Start Date
November 1 2023
End Date
November 1 2024
Last Update
November 18 2023
Active Locations (1)
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1
Zhenyu Zhang
Nanjing, Jiangsu, China, 210000