FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019852 [Registered on: 25/06/2019] Trial Registered Prospectively
Last Modified On: 16/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of dietary modification in patients with functional dyspepsia 
Scientific Title of Study   To study the effect of low FODMAP diet on symptoms and quality of life in patients with Functional Dyspepsia 
Trial Acronym  FFD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Omesh Goyal 
Designation  Associate Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Room no 9, OPD block Department of Gastroenterology Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  01614688800  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DR Omesh Goyal 
Designation  Associate Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Room no 9, OPD block Department of Gastroenterology Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India


PUNJAB
141001
India 
Phone  01614688800  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR Omesh Goyal 
Designation  Associate Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Room no 9, OPD block Department of Gastroenterology Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India


PUNJAB
141001
India 
Phone  01614688800  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India  
 
Primary Sponsor  
Name  Dept of Gastroenterology 
Address  Department of Gastroenterology Dayanand Medical College and Hospital, Ludhiana, India Ludhiana PUNJAB 141001 India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Omesh Goyal  Dayanand Medical college and Hospital  Gastroenterology OPD (Room 1 and 9), O.P.D. complex, Tagore Nagar Ludhiana Ludhiana PUNJAB
Ludhiana
PUNJAB 
01614688800

goyalomesh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low FODMAP diet (fermentable oligosaccharides, monosaccharides, disaccharides and polyols)   The low FODMAP diet implies a restricted intake of foods containing fermentable oligosaccharides, monosaccharides, disaccharides and polyols. The patients will be instructed to avoid food sources rich in fructans and galacto-oligosaccharides (GOS), such as wheat, rye, barley, onion and legumes, lactose-containing products, foods with “free fructose” (i.e. fructose in excess of glucose), such as apples, pears, watermelon, asparagus and honey, and food items rich in sorbitol, mannitol, maltitol and xylitol, such as apricots, peaches and artificially sweetened products. Duration- 4 weeks Frequency- as per daily requirement  
Comparator Agent  Traditional diet  Patient will be asked to consume his/her regular diet with traditional dietary advise for dyspepsia as follows: 1. Eating smaller, regular, low-fat meals 2. Avoiding trigger like fatty, fried or spicy foods, and carbonated drinks 3. Avoidance of non-steroidal anti-inflammatory drugs, coffee, alcohol, and smoking. Duration- 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age- 18-70 years
2. FD diagnosed according to ROME IV criteria.
3. Patients having inadequate relief of dyspepsia symptoms on current medications.
4. Upper GI Endoscopy negative for any organic cause for dyspepsia performed in the last 2 years.
5. H pylori infection negative by non-invasive testing or biopsy.
6. Celiac disease excluded by serology and/or biopsy 
 
ExclusionCriteria 
Details  1. Presence of alarm symptoms like loss of appetite, loss of weight, dysphagia, anemia, new onset dyspepsia after 50 years age, hematemesis/malena, severe pain abdomen
2. Presence of a severe cardiac, liver, neurological or psychiatric disease
3. Predominant symptoms of another GI disease (e.g. IBS, GERD, gastroparesis, inflammatory bowel disease, Functional constipation/diarrhoea) that could explain the current symptoms.
4. Patients who are already on a diet excessively restricting certain nutrients before entering the study (e.g. low in FODMAPs, gluten-free, lactose free diet).
5. Prescription of bowel preparation for investigative procedures, antibiotic therapy, prebiotics or probiotics, and change of dyspepsia medication during the previous four weeks.
6. History of surgery involving upper GI tract
7. History of lactose/fructose intolerance, unless symptoms persist on a lactose/fructose free diet
8. Pregnant or lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of responders (symptom relief)
 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life
 
four weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2019 
Date of Study Completion (India) 21/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Functional Dyspepsia (FD) is a functional bowel disorder with significant global prevalence and contributes up to one third of gastroenterology outpatient appointments. It profoundly affects health-related quality of life likely due to its chronic nature and the co-existence of gastrointestinal (GI) and extra-intestinal symptoms. Currently, the gold standard for the diagnosis of FD is the Rome IV criteria. Rome IV subdivides FD into two sub groups, dependent on whether the symptoms are meal-related, the post prandial distress syndrome, or not, the epigastric pan syndrome. Currently, there are no reliable biomarkers to aid in the diagnosis of FD.

Current pathophysiological mechanisms implicated in the pathogenesis of FD include altered motility especially impaired accommodation and gastric emptying, visceral hypersensitivity, low-grade mucosal inflammation, dysbiosis of the gut microbiota, and abnormal central pain processing. There appears to be a degree of overlap with the mechanisms that are implicated in the pathogenesis of IBS. Furthermore, subjects with FD also have prominent “gas” related symptoms including bloating, belching, and distension. Subjects with FD also experience epigastric/abdominal pain and discomfort, and, in the prandial dis- tress syndrome sub-group, these symptoms are exclusively meal- related. This has led to researchers involved in FGID research to question whether FD and IBS are in fact two separate but related diseases, or simply one disease process with varying phenotypes

An incomplete understanding of the pathophysiology of IBS and its phenotypic heterogeneity has led to symptom-directed treatment approaches including PPI, prokinetics and anti-psychotics. However, less than one third of patients are satisfied with their current treatments. Dietary restriction of fermentable carbohydrates (low FODMAP diet) is now widely used in the management of IBS. These carbohydrates increase small intestinal water and colonic gas. Their dietary restriction has been investigated in few trials with up to 70% of patients reporting symptomatic benefit.  However there is not even a single randomized study evaluating the effect of low FODMAP diet in FD patients, which motivated us to conduct this study.

 

 
Close