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CTRI Number  CTRI/2019/02/017450 [Registered on: 05/02/2019] Trial Registered Prospectively
Last Modified On: 28/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Diet Restrictions (Low FODMAP)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the efficacy of a restricted diet in improving symptoms in patients with Irritable bowel syndrome 
Scientific Title of Study   Role of low FODMAP diet in patients with Irritable bowel syndrome (IBS) : a randomized trial 
Trial Acronym  FIBS 
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 
Phone  9914821155  
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 
Phone  9914821155  
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 
Phone  9914821155  
Fax    
Email  goyalomesh@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India 141001 
 
Primary Sponsor  
Name  Department of Gastroenterology 
Address  Dayanand Medical College and Hospital, Ludhiana, India 141001 
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,  Room No 9, OPD block, Department of Gastroenterology, Ludhiana, India 141001
Ludhiana
PUNJAB 		 9914821155

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: K580||Irritable bowel syndrome with diarrhea,  
 
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. 
Comparator Agent  Modified NICE Diet   Modified NICE Diet implies a greater focus on how and when to eat rather than on what foods to ingest. The diet is based on the dietary recommendations from NICE and the British Dietary Association. Specifically, the participants will be instructed to eat regularly three meals and three snacks a day, never too much or too little each time, never to be hungry or too full; to eat in peace and quiet and to chew thoroughly; reduce intake of fatty or spicy foods, coffee, alcohol, onions, cabbage and beans; avoid soft drinks and carbonated beverages, chewing gums and sweeteners that ends with –ol, and to eat fibers but distribute the intake evenly over the day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. IBS-D diagnosed according to ROME IV criteria.
2. Age- 18-70 years
3. Currently having medium-severe symptoms [as indicated by IBS Symptom Severity Score (IBS-SSS) ≥17.5] 
 
ExclusionCriteria 
Details  1. Presence of a severe cardiac, liver, neurological or psychiatric disease
2. Presence of another GI disease than IBS (e.g. inflammatory bowel disease, celiac disease) that could explain the current symptoms.
3. Patients with IBS –Constipation predominant
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 to IBS medication during the previous four weeks.
 
 
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 
Change in IBS-SSS (symptom severity score)  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in stool frequency
2. Change in nutrient intake  		 4 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2019 
Date of Study Completion (India) 05/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Irritable bowel syndrome (IBS) is a functional bowel disorder with a global prevalence of 11% and contributes up to 60% 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. An incomplete understanding of the pathophysiology of IBS and its phenotypic heterogeneity has led to symptom-directed treatment approaches including antispasmodics and anti-diarrheals. However, less than 40% of patients are satisfied with their current treatments.  Dietary restriction of fermentable carbohydrates (fermentable oligosaccharides, monosaccharides, disaccharides and polyols- FODMAP) is now widely used in the management of IBSD. 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 on Indian population evaluating effect of low FODMAP diet in IBSD patients, which motivated us to conduct this study.

 
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