Food HabitsNCT02902926
Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
A study testing Low FODMAPs Diet and Diet instruction in people with Food Habits, run by Jinsong Wang at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Food Habits
- What is being tested?
- Low FODMAPs Diet and Diet instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
YangzhouUniversity
Yangzhou, Jiangsu, 225001
Yamei Gu, Dr., +8615252573426, 286508374@qq.com
Tianqi Zhou, Dr., +8618852727248, 651299080@qq.com
About this study
Official title: Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
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.
Read the 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.
- Conditions
- Food Habits
- Being tested
- Low FODMAPs Diet, Diet instruction
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAPs DietBehavioural
Instruct to design and eat Low Fermentable，Oligo-，Di-，Mono-saccharides And Polyols(FODMAPs) Diet
Diet instructionBehavioural
Answer the doubt and help the patient get the diet knowlege about the IBS.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Diet instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota / Short chain fatty acids
The fecal samples of IBS patients were analyzed.
Measured: Change from baseline Microbiota / Short chain fatty acids at 4 weeks
Secondary outcomes (4)
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
Measured: Baseline,1,and 3 month post randomization
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
Measured: Baseline,1,and 3 month post randomization
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.
Measured: Baseline,1,and 3 month post randomization
Satisfaction questionnaire
To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items
Measured: 1,and 3 month post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinsong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinsong Wang, Yangzhou University
- Investigators
- Hongcan Shi, Ph.D.,M.D., Study chair, Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902926
- Sponsor's protocol ID
- 20160805
- Status last verified
- Sep 2016
- First submitted
- 15 Aug 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25199904Lovell 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.
PubMed 22426087Eswaran 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.
PubMed 21333905Bohn 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.
PubMed 23644955Iacovou 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.
PubMed 26350937De 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.
PubMed 26078292Gibson 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.
PubMed 25680668Hyland 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.
PubMed 25083059Jain 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.
PubMed 25872243Halmos 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.
PubMed 24076059Bohn 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.
PubMed 26255043Whigham 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.
PubMed 25871564Marsh 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.
PubMed 25982757Chumpitazi 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.
PubMed 26104013
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02902926
- Acronym / sponsor ID
- 20160805
- Conditions
- Food Habits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jinsong WangUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FODMAPs Diet | Experimental | Behavioral: Low FODMAPs Diet, Behavioral: Diet instruction1. 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. |
| Diet Instruction | Placebo comparator | Behavioral: Diet instruction1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low FODMAPs DietInstruct to design and eat Low Fermentable，Oligo-，Di-，Mono-saccharides And Polyols(FODMAPs) Diet | Behavioural | Low FODMAPs Diet |
| Diet instructionAnswer the doubt and help the patient get the diet knowlege about the IBS. | Behavioural | Diet Instruction, Low FODMAPs Diet |
Primary outcome
Microbiota / Short chain fatty acids
Time frame: Change from baseline Microbiota / Short chain fatty acids at 4 weeks
The fecal samples of IBS patients were analyzed.
4 secondary outcomes
Irritable bowel syndrome severity scoring system scale
Time frame: Baseline,1,and 3 month post randomization
The Short Form 36 (SF-36) scale
Time frame: Baseline,1,and 3 month post randomization
Irritable bowel syndrome quality of life (IBS-QOL) scale
Time frame: Baseline,1,and 3 month post randomization
Satisfaction questionnaire
Time frame: 1,and 3 month post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Results publication: PubMed 25199904Canavan 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 publication: PubMed 22426087Lovell 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 publication: PubMed 21333905Eswaran 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 publication: PubMed 23644955Bohn 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 publication: PubMed 26350937Iacovou 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 publication: PubMed 26078292De 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 publication: PubMed 25680668Gibson 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 publication: PubMed 25083059Hyland 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 publication: PubMed 25872243Jain 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 publication: PubMed 24076059Halmos 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 publication: PubMed 26255043Bohn 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 publication: PubMed 25871564Whigham 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.
- Monash University, D.o.G., The Monash University low FODMAP diet app. Melbourne Australia: Central Clinical School 2015 \[updated 28 May 2015; cited 2015 4 June\].Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Food Habits
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Recruiting
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Enrolling by invitationObservational study
NutFinForce - Lifestyle Performance Medicine Intervention on Defense Performance in Finland
No Condition
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongcan Shi, Ph.D.,M.D. study chair
Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAPs Diet and Diet instruction in people with Food Habits, run by Jinsong Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianqi Zhou, Dr. (+8618852727248, 651299080@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota / Short chain fatty acids (time frame: Change from baseline Microbiota / Short chain fatty acids at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902926, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.