Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
Primary Purpose
Food Habits
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low FODMAPs Diet
Diet instruction
Sponsored by
About this trial
This is an interventional treatment trial for Food Habits
Eligibility Criteria
Inclusion Criteria:
- Diagnostic criteria for Rome Ⅲ
- IBS patients with diarrhea type
- By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease
- Patients be able to communicate well with the researchers and be willing to participate in the study
Exclusion Criteria:
- Stomach, small intestine, colon surgery history
- irritable bowel disease (IBD) active period, celiac disease
- Alcoholics or drug abuse
- Pregnant or lactating women
- Recent drug users who use defecation
- Have a special diet
Sites / Locations
- YangzhouUniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Low FODMAPs Diet
Diet Instruction
Arm Description
Instructed to low FODMAPs diet when patients signed the informed consent. Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
Outcomes
Primary Outcome Measures
Microbiota / Short chain fatty acids
The fecal samples of IBS patients were analyzed.
Secondary Outcome Measures
Irritable bowel syndrome severity scoring system scale
Irritable bowel syndrome severity scoring system scale is an integral system for monitoring the severity of IBS in patients with disease severity.The scale is mainly from the degree of abdominal pain, abdominal pain frequency, abdominal distension, defecation satisfaction and the impact of life, according to the 10cm visual scoring method
The Short Form 36 (SF-36) scale
SF-36 is a general scale, at present, the most commonly used evaluation of IBS. It includes 36 items, a total of 8 dimensions
Irritable bowel syndrome quality of life (IBS-QOL) scale
Irritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS.
Satisfaction questionnaire
To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02902926
Brief Title
Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
Official Title
Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jinsong Wang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present,a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.
Detailed Description
IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present,a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.
This study will compare the effect of low FODMAPs diet and usual diet instruction on Intestinal flora, intestinal short chain fatty acids and quality of life by two groups.The results will answer the effect and long-term safety of Low FODMAPs diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Habits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low FODMAPs Diet
Arm Type
Experimental
Arm Description
Instructed to low FODMAPs diet when patients signed the informed consent.
Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
Arm Title
Diet Instruction
Arm Type
Placebo Comparator
Arm Description
1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
Intervention Type
Behavioral
Intervention Name(s)
Low FODMAPs Diet
Intervention Description
Instruct to design and eat Low Fermentable,Oligo-,Di-,Mono-saccharides And Polyols(FODMAPs) Diet
Intervention Type
Behavioral
Intervention Name(s)
Diet instruction
Intervention Description
Answer the doubt and help the patient get the diet knowlege about the IBS.
Primary Outcome Measure Information:
Title
Microbiota / Short chain fatty acids
Description
The fecal samples of IBS patients were analyzed.
Time Frame
Change from baseline Microbiota / Short chain fatty acids at 4 weeks
Secondary Outcome Measure Information:
Title
Irritable bowel syndrome severity scoring system scale
Description
Irritable bowel syndrome severity scoring system scale is an integral system for monitoring the severity of IBS in patients with disease severity.The scale is mainly from the degree of abdominal pain, abdominal pain frequency, abdominal distension, defecation satisfaction and the impact of life, according to the 10cm visual scoring method
Time Frame
Baseline,1,and 3 month post randomization
Title
The Short Form 36 (SF-36) scale
Description
SF-36 is a general scale, at present, the most commonly used evaluation of IBS. It includes 36 items, a total of 8 dimensions
Time Frame
Baseline,1,and 3 month post randomization
Title
Irritable bowel syndrome quality of life (IBS-QOL) scale
Description
Irritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS.
Time Frame
Baseline,1,and 3 month post randomization
Title
Satisfaction questionnaire
Description
To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items
Time Frame
1,and 3 month post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic criteria for Rome Ⅲ
IBS patients with diarrhea type
By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease
Patients be able to communicate well with the researchers and be willing to participate in the study
Exclusion Criteria:
Stomach, small intestine, colon surgery history
irritable bowel disease (IBD) active period, celiac disease
Alcoholics or drug abuse
Pregnant or lactating women
Recent drug users who use defecation
Have a special diet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tianqi Zhou, Dr.
Phone
+8618852727248
Email
651299080@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yamei Gu, Dr.
Phone
15252573426
Email
286508374@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongcan Shi, Ph.D.,M.D.
Organizational Affiliation
Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
YangzhouUniversity
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Gu, Dr.
Phone
+8615252573426
Email
286508374@qq.com
First Name & Middle Initial & Last Name & Degree
Tianqi Zhou, Dr.
Phone
+8618852727248
Email
651299080@qq.com
First Name & Middle Initial & Last Name & Degree
Jinsong Wang, Ph.D.,M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25199904
Citation
Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.
Results Reference
result
PubMed Identifier
22426087
Citation
Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
Results Reference
result
PubMed Identifier
21333905
Citation
Eswaran S, Tack J, Chey WD. Food: the forgotten factor in the irritable bowel syndrome. Gastroenterol Clin North Am. 2011 Mar;40(1):141-62. doi: 10.1016/j.gtc.2010.12.012.
Results Reference
result
PubMed Identifier
23644955
Citation
Bohn L, Storsrud S, Tornblom H, Bengtsson U, Simren M. Self-reported food-related gastrointestinal symptoms in IBS are common and associated with more severe symptoms and reduced quality of life. Am J Gastroenterol. 2013 May;108(5):634-41. doi: 10.1038/ajg.2013.105.
Results Reference
result
PubMed Identifier
26350937
Citation
Iacovou M, Tan V, Muir JG, Gibson PR. The Low FODMAP Diet and Its Application in East and Southeast Asia. J Neurogastroenterol Motil. 2015 Oct 1;21(4):459-70. doi: 10.5056/jnm15111.
Results Reference
result
PubMed Identifier
26078292
Citation
De Giorgio R, Volta U, Gibson PR. Sensitivity to wheat, gluten and FODMAPs in IBS: facts or fiction? Gut. 2016 Jan;65(1):169-78. doi: 10.1136/gutjnl-2015-309757. Epub 2015 Jun 15.
Results Reference
result
PubMed Identifier
25680668
Citation
Gibson PR, Varney J, Malakar S, Muir JG. Food components and irritable bowel syndrome. Gastroenterology. 2015 May;148(6):1158-74.e4. doi: 10.1053/j.gastro.2015.02.005. Epub 2015 Feb 11.
Results Reference
result
PubMed Identifier
25083059
Citation
Hyland NP, Quigley EM, Brint E. Microbiota-host interactions in irritable bowel syndrome: epithelial barrier, immune regulation and brain-gut interactions. World J Gastroenterol. 2014 Jul 21;20(27):8859-66. doi: 10.3748/wjg.v20.i27.8859.
Results Reference
result
PubMed Identifier
25872243
Citation
Jain I, Kumar V, Satyanarayana T. Xylooligosaccharides: an economical prebiotic from agroresidues and their health benefits. Indian J Exp Biol. 2015 Mar;53(3):131-42.
Results Reference
result
PubMed Identifier
24076059
Citation
Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
Results Reference
result
PubMed Identifier
26255043
Citation
Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
Results Reference
result
PubMed Identifier
25871564
Citation
Whigham L, Joyce T, Harper G, Irving PM, Staudacher HM, Whelan K, Lomer MC. Clinical effectiveness and economic costs of group versus one-to-one education for short-chain fermentable carbohydrate restriction (low FODMAP diet) in the management of irritable bowel syndrome. J Hum Nutr Diet. 2015 Dec;28(6):687-96. doi: 10.1111/jhn.12318. Epub 2015 Apr 14.
Results Reference
result
PubMed Identifier
25982757
Citation
Marsh A, Eslick EM, Eslick GD. Does a diet low in FODMAPs reduce symptoms associated with functional gastrointestinal disorders? A comprehensive systematic review and meta-analysis. Eur J Nutr. 2016 Apr;55(3):897-906. doi: 10.1007/s00394-015-0922-1. Epub 2015 May 17.
Results Reference
result
PubMed Identifier
26104013
Citation
Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.
Results Reference
result
Links:
URL
http://www.med.monash.edu.au/cecs/gastro/fodmap/iphone-app.html
Description
Monash University, D.o.G., The Monash University low FODMAP diet app. Melbourne Australia: Central Clinical School 2015 [updated 28 May 2015; cited 2015 4 June].
Learn more about this trial
Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
We'll reach out to this number within 24 hrs