Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients

Food Habits Clinical Trial

Official title:

Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902926
• Other study ID #: 20160805
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2016
• Last updated: September 12, 2016
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Yangzhou University
• Contact: Tianqi Zhou, Dr.
• Phone: +8618852727248
• Email: 651299080[@]qq.com
• Is FDA regulated: No
• Health authority: China: YangZhou Science and Technology Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnostic criteria for Rome ?

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food Habits
• Irritable Bowel Syndrome

Intervention

Behavioral:
• Low FODMAPs Diet
Instruct to design and eat Low Fermentable,Oligo-,Di-,Mono-saccharides And Polyols(FODMAPs) Diet
• Diet instruction
Answer the doubt and help the patient get the diet knowlege about the IBS.

Locations

Country	Name	City	State
China	YangzhouUniversity	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinsong Wang

Country where clinical trial is conducted

China, 

References & Publications (14)

Böhn L, Störsrud S, Liljebo T, Collin L, Lindfors P, Törnblom H, Simrén 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.e — View Citation

Böhn L, Störsrud S, Törnblom H, Bengtsson U, Simrén 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/aj — View 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. Review. — View 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. Al — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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 — View 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 irritabl — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota / Short chain fatty acids	The fecal samples of IBS patients were analyzed.	Change from baseline Microbiota / Short chain fatty acids at 4 weeks	No
Secondary	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	Baseline,1,and 3 month post randomization	No
Secondary	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	Baseline,1,and 3 month post randomization	No
Secondary	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.	Baseline,1,and 3 month post randomization	No
Secondary	Satisfaction questionnaire	To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items	1,and 3 month post randomization	No

External Links

•   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].
•   University., M., The Monash University Low FODMAP diet booklet. 5 ed. Melbourne, Australia: Department of Gastroenterology, Central Clinical School 2015.