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

NCT02902926 | Unknown DMC

• 1 other identifier: 20160805
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Habits

Outcome Measures

Primary Outcomes (1)

• Microbiota / Short chain fatty acids

  The fecal samples of IBS patients were analyzed.

  Change from baseline Microbiota / Short chain fatty acids at 4 weeks

Secondary Outcomes (4)

• Irritable bowel syndrome severity scoring system scale

  Baseline,1,and 3 month post randomization

• The Short Form 36 (SF-36) scale

  Baseline,1,and 3 month post randomization

• Irritable bowel syndrome quality of life (IBS-QOL) scale

  Baseline,1,and 3 month post randomization

• Satisfaction questionnaire

  1,and 3 month post randomization

Study Arms (2)

Low FODMAPs Diet

EXPERIMENTAL

1. Instructed to low FODMAPs diet when patients signed the informed consent. 2. Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.

Behavioral: Low FODMAPs Diet; Behavioral: Diet instruction

Diet Instruction

PLACEBO COMPARATOR

1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.

Behavioral: Diet instruction

Interventions

Low FODMAPs Diet BEHAVIORAL

Instruct to design and eat Low Fermentable，Oligo-，Di-，Mono-saccharides And Polyols(FODMAPs) Diet

Low FODMAPs Diet

Diet instruction BEHAVIORAL

Answer the doubt and help the patient get the diet knowlege about the IBS.

Diet Instruction; Low FODMAPs Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinsong Wang: lead

Study Sites (1)

YangzhouUniversity

Yangzhou, Jiangsu, 225001, China

RECRUITING

Related Publications (14)

• 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.

  PMID: 25199904 RESULT

• 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.

  PMID: 22426087 RESULT

• 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.

  PMID: 21333905 RESULT

• 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.

  PMID: 23644955 RESULT

• 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.

  PMID: 26350937 RESULT

• 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.

  PMID: 26078292 RESULT

• 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.

  PMID: 25680668 RESULT

• 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.

  PMID: 25083059 RESULT

• 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.

  PMID: 25872243 RESULT

• 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.

  PMID: 24076059 RESULT

• 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.

  PMID: 26255043 RESULT

• 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.

  PMID: 25871564 RESULT

• 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.

  PMID: 25982757 RESULT

• 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.

  PMID: 26104013 RESULT

Related Links

• Monash University, D.o.G., The Monash University low FODMAP diet app. Melbourne Australia: Central Clinical School 2015 \[updated 28 May 2015; cited 2015 4 June\].

MeSH Terms

Conditions

Feeding Behavior

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hongcan Shi, Ph.D.,M.D.

  Medical College

  STUDY CHAIR

Central Study Contacts

Tianqi Zhou, Dr.

CONTACT

+8618852727248; 651299080@qq.com

Yamei Gu, Dr.

CONTACT

15252573426; 286508374@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Center for Clincal Epidemiology

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)