Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment
1 other identifier
interventional
132
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2020
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 10, 2020
February 1, 2020
1 year
February 21, 2020
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in composition of gut microbiota
To study changes from baseline in composition of gut microbiota including gastric H. pylori, gastric atrophy (PG-I, PG-II ratio
Baseline upto 6 months
Hospital anxiety and depression score
Number of items in the questionnaire reflects anxiety and depression. Each item had been answered by the patient on a four point (0-3) response category and the possible scores ranged from 0-21 for depression (0-7 score indicates normal range, 8-10 indicates 'borderline abnormal or borderline case' and a score of 11 or higher indicates 'abnormal case'.
Baseline upto 6 months
Secondary Outcomes (1)
Sleep quality index score
Baseline upto 6 months
Study Arms (2)
Rifaximin
ACTIVE COMPARATORRifaximin 550mg thrice daily for 14 days Other Name: Normix
Placebo
PLACEBO COMPARATORPlacebo thrice daily for 14 days
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Critical Care Medicine, SGPGIMS
Lucknow, Uttar Pradesh, 226014, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, 226014, India
Related Publications (2)
Li X, Cao Y, Wong RK, Ho KY, Wilder-Smith CH. Visceral and somatic sensory function in functional dyspepsia. Neurogastroenterol Motil. 2013 Mar;25(3):246-53, e165. doi: 10.1111/nmo.12044. Epub 2012 Nov 21.
PMID: 23171089RESULTSebastian-Domingo JJ. [Integrative medicine in the management of functional dyspepsia. Role of the herbal preparation STW5]. Gastroenterol Hepatol. 2014 Apr;37(4):256-61. doi: 10.1016/j.gastrohep.2013.10.001. Epub 2013 Dec 5. Spanish.
PMID: 24314790RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Uday C Ghoshal
Medical council of India, Association of Indian Universities
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
March 10, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2021
Study Completion
March 1, 2023
Last Updated
March 10, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
This study will be conducted in the Department of Gastroenterology, in inter-institutional collaboration with Dr. Mojibur R. Khan (Gut Microbiome expert) from Life Science Division, Institute of Advanced Study in Science and Technology (IASST) and in inter-departmental collaborations with the department of Microbiology having patients with clinical suspicion with FD and facility for laboratory works.