Status:
UNKNOWN
Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Collaborating Sponsors:
Institute of Advanced Study in Science and Technology
Conditions:
Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Functional dyspepsia (FD) is a common condition associated with significant morbidity, healthcare expenditure, work absenteeism and productivity, and reduced quality of life. The prevalence of this co...
Detailed Description
Functional dyspepsia (FD) is a common clinical syndrome characterized by the presence of recurrent or chronic upper abdominal symptoms, such as epigastric pain, early satiety, and fullness, without an...
Eligibility Criteria
Inclusion
- FD diagnosis by ROME IV criteria (one or more of bothersome symptoms like postprandial fullness, early satiation, epigastric pain, and epigastric burning. It must include criteria for postprandial distress syndrome and epigastric pain syndrome for the last 3 months with symptom onset at least 6 months before diagnosis and no evidence of structural disease, including upper endoscopy).
- No organic disease on upper gastrointestinal endoscopy and ultrasound.
- Currently, not on any active therapy during the last two months.
- No previous history of Helicobacter pylori eradication.
- No antibiotic therapy within the last month.
- Not received proton pump inhibitors for a minimum of 4 weeks prior to study enrollment.
Exclusion
- Presence of alarm symptoms such as GI bleeding, unexplained iron deficiency anemia, unintentional weight loss, palpable abdominal mass, family history of colon or stomach cancer or symptom onset ≥50 years of age and not yet screened for colon cancer, or sudden/acute onset of a new change in bowel habit)
- No proper informed consent.
- Endoscopic treatment for gastroesophageal reflux.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04302402
Start Date
March 1 2020
End Date
March 1 2023
Last Update
March 10 2020
Active Locations (2)
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1
Department of Critical Care Medicine, SGPGIMS
Lucknow, Uttar Pradesh, India, 226014
2
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, India, 226014