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Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment

NCT04302402 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2020-03-10

No results posted yet for this study

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 condition is as high as 15% in the rural (Jaunpur district, Uttar Pradesh) and 30% of the urban (Mumbai) Indian population. Pathophysiologically, FD is an enigmatic condition that may be contributed by a variable combination of psychosocial issues like anxiety, depression, insomnia, and micro-organic issues like Helicobacter pylori infection, gastritis, duodenitis, hypersecretion of acid, degree of gastric atrophy, gastric microbiota dysbiosis. Accordingly, investigators want to study these factors among patients with FD. Rifaximin has been shown to be useful in the treatment of FD in a recent randomized controlled trial from Hong Kong. Since microbiota dysbiosis may be an important issue in FD, investigators want to treat them with rifaximin in a randomized placebo-controlled trial and repeat the parameters such as dyspepsia score, hospital Anxiety and Depression Scale (HADS) score, Pittsburgh Sleep Quality Index (PSQI). Investigators wish to study the pathogenetic mechanism of FD and evaluate baseline factors that may help to predict response to gut microbiota manipulation in these patients. Objectives: a. To study the patients with FD for gut microbiota including gastric H. pylori, gastric atrophy (by PG-1 PG-II ratio), hospital anxiety and depression score, and sleep disorders b. To see the effect of treatment of these patients with rifaximin vs. placebo in a randomized controlled trial not only for the improvement in symptoms but also for improvement in HADS score and sleep quality c. To study whether any pre-treatment factors including gut microbiota predict the response of symptoms to treatment with rifaximin.

Conditions

  • Dyspepsia

Interventions

DRUG

Rifaximin

Rifaximin has been demonstrated in multiple IBS studies, through a postulated effect on the gut microbiota, to improve the symptoms of pain and bloating, which are important symptoms in subjects with functional dyspepsia

DRUG

Placebo

Similar looking placebo

Sponsors & Collaborators

  • Institute of Advanced Study in Science and Technology

    collaborator UNKNOWN

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Uday C Ghoshal · Medical council of India, Association of Indian Universities

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-03-31
Completion
2023-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04302402 on ClinicalTrials.gov