| 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
|
|
|
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
|
|
|
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. |