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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Collaborator: Institute of Advanced Study in Science and Technology
• Treatments: Rifaximin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.