Irritable Bowel SyndromeNCT03304041
Efficacy of Low-FODMAPs Dietary Therapy for Irritable Bowel Syndrome in China
A study testing low-FODMAPs diet and Traditional dietary advice in people with Irritable Bowel Syndrome and Diet Modification, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The primary aim of our study is to carry out a randomized trial to evaluate the efficacy of low-FODMAPs dietary therapy compared to conventional therapy for IBS patients recruited from tertiary hospitals in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Diet Modification
- What is being tested?
- low-FODMAPs diet and Traditional dietary advice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2017to 31 May 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old.
- Meet Rome Rome III criteria for IBS-D.
- All these patients should have no abnormality in blood, stool analysis or colonoscopy within the previous 2 years.
- No GI alarm symptoms.
Who cannot join
- Presence of a severe cardiac, hepatic, nephritic, neurologic disease.
- Presence of mental disorders caused by schizophrenia, organic brain disorder or physical disease.
- Other comorbid medical conditions (eg.unstable diabetes, unstable thyroid disease).
- Previous abdominal surgery except appendectomy or hysterectomy.
- Pregnant or lactating women.
- Use of probiotics, prebiotics, lactulose, antidiarrheal agents or bowel preparation within the 4 weeks prior to the study.
- Participation in any other form of dietary therapy within the 4 weeks prior to the study.
- Difficulties in communication.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
About this study
Official title: Efficacy of Low-FODMAPs Dietary Therapy Versus Traditional Dietary Advice for Diarrhea-predominant Irritable Bowel Syndrome in China - A Prospective Randomized Controlled Trial
The primary aim of our study is to carry out a randomized trial to evaluate the efficacy of low-FODMAPs dietary therapy compared to conventional therapy for IBS patients recruited from tertiary hospitals in China. Secondary aims of this research include an analysis of clinical, physiological and microbiological factors that may predict IBS patient response to this dietary intervention.
Read the detailed description
Visit 1：Enrollment \& Screening \& Run-in period Patients who meet the inclusion criteria will be asked to complete IBS Baseline Assessment Questionnaires according to Rome III.Subjects that meet the criteria will receive verbal and written information about the study and provide written informed consent. After meeting with the dietitian and physician who will provide instructions, they will be asked to complete Combined Nutrient and Lactulose Breath Test.[16] Additionally, a baseline food and symptom diary will be completed in a (minimum) 14 day run-in period after breath test (the first 48hr after the breath test will not be included in this analysis). This diary record prior to the intervention will document baseline symptom severity and capture the habitual diet of IBS patients.
Visit 2: Randomization \& Intervention. After the run-in period, patients will come back to the clinic to receive dietary instruction ahead of starting the intervention. At the same visit subjects will provide fresh stool for fermentation analysis (including short chain fatty acids and pressure detection) and blood for cytokines analysis. Subjects will then be randomly assigned to either low FODMAP diet (LFD) group or traditional dietary advice for IBS (TDA) group by computer-generated random number table. Participants will receive food instructions by a dietitian, according to their assignment. Throughout the study, only the dietitian will be aware of the assignment of the intervention given. Both diet therapy will last for 3 weeks, and all the subjects are instructed to complete daily food and symptom diary through a provided booklet. IBS Symptoms Severity Scores (IBS-SSS) is evaluated every week and the dietitian who is not aware of the allocation will make a telephone follow-up to assess patient adherence.
Visit 3: End of treatment \& Follow-up. After 3 weeks of intervention, the participants will attend a follow-up appointment and complete the IBS Post-Intervention Assessment Questionnaires. Fresh stools and blood are recollected at this visit to evaluate for possible change in gut microbiota and cytokines after diet intervention.
- Conditions
- Irritable Bowel Syndrome, Diet Modification
- Being tested
- low-FODMAPs diet, Traditional dietary advice
- Keywords
- low-FODMAP, Irritable Bowel Syndrome, stool fermentation, Breath test
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-FODMAPs dietDietary supplement
The low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data.
low-FODMAPs diet therapy for 3 weeks
Traditional dietary adviceDietary supplement
Traditional dietary advice(TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period
traditional dietary advice for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| low-FODMAPs diet | Experimental | The low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data.
low-FODMAPs diet therapy for 3 weeks Receives: Dietary Supplement: low-FODMAPs diet |
| Traditional dietary advice | Placebo comparator | Traditional dietary advice (TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period
Traditional dietary advice for 3 weeks Receives: Dietary Supplement: Traditional dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare response to diet intervention between different groups.
Primary endpoint will be response to 3-week of diet intervention defined by shows >50 point reduction in IBS-SSS between baseline and post-intervention scores. The proportion of responders who met primary endpoint in each group will be compared.
Measured: three weeks
Secondary outcomes (12)
Improvement in abdominal pain between different groups.
Compare improvement about abdominal pain during 3-week intervention period between different groups according to Food and Drug Administration (FDA) individual composite end point (≥30% reduction in mean daily abdominal pain score).
Measured: Three weeks
Improvement in stool consistency between different groups.
Compare improvement about stool consistency during 3-week intervention period between different groups according to Food and Drug Administration (FDA) individual composite end point (a decrease in mean daily Bristol Stool Score (BSS) value of ≥1 compared with baseline for any 2 weeks of the intervention period).
Measured: Three weeks
Compare changes from baseline in abdominal pain score between different groups.
Compare group changes from baseline in abdominal pain score，averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in abdominal frequency between different groups.
Compare group changes from baseline in abdominal frequency, averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in bloating score between different groups.
Compare group changes from baseline in bloating score, averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in excessive wind score between different groups.
Compare group changes from baseline in excessive wind score, averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in stool consistency between different groups.
Compare group changes from baseline in stool consistency as measured by BSS, averaged over each treatment week for total three weeks..
Measured: Every week, last for three weeks
Compare changes from baseline in stool frequency between different groups.
Compare group changes from baseline in stool frequency, averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in urgency score between different groups.
Compare group changes from baseline in urgency score, averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in incomplete defecation score between different groups.
Compare group changes from baseline in incomplete defecation score, averaged over each treatment week for total three weeks.
Measured: Every week, last for three weeks
Compare changes from baseline in quality of life between different groups.
Compare group changes between baseline and post-intervention(3 weeks later) about quality of life evaluated by IBS-QOL.
Measured: Three weeks
Compare changes from baseline in mental health between different groups.
Compare group changes between baseline and post-intervention(3 weeks later) about mental health evaluated by GAD-7 and PHQ-9.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start10 Oct 2017
- Primary completion31 May 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Academy of Agricultural Sciences, University of Michigan, Klinik Arlesheim
- Responsible party
- Principal investigator, DAI Ning, Sir Run Run Shaw Hospital
- Investigators
- Yawen Zhang, MM, Principal investigator, Sir Run Run Shaw HospitalLijun Feng, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304041
- Sponsor's protocol ID
- 20170116-2
- Status last verified
- Sep 2019
- First submitted
- 20 Jul 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Feng L, Wang X, Fox M, Luo L, Du L, Chen B, Chen X, He H, Zhu S, Hu Z, Chen S, Long Y, Zhu Y, Xu L, Deng Y, Misselwitz B, Lang BM, Yilmaz B, Kim JJ, Owyang C, Dai N. Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet compared with traditional dietary advice for diarrhea-predominant irritable bowel syndrome: a parallel-group, randomized controlled trial with analysis of clinical and microbiological factors associated with patient outcomes. Am J Clin Nutr. 2021 Jun 1;113(6):1531-1545. doi: 10.1093/ajcn/nqab005.
PubMed 33740048
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-FODMAPs Dietary Therapy Versus Traditional Dietary Advice for Diarrhea-predominant Irritable Bowel Syndrome in China - A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03304041
- Acronym / sponsor ID
- 20170116-2
- Conditions
- Irritable Bowel Syndrome, Diet Modification
- Keywords
- low-FODMAP, Irritable Bowel Syndrome, stool fermentation, Breath test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Academy of Agricultural Sciences, University of Michigan, Klinik Arlesheim
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 6 Oct 2017 (actual)
- 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.
The primary aim of our study is to carry out a randomized trial to evaluate the efficacy of low-FODMAPs dietary therapy compared to conventional therapy for IBS patients recruited from tertiary hospitals in China. Secondary aims of this research include an analysis of clinical, physiological and microbiological factors that may predict IBS patient response to this dietary intervention.
Detailed description
Visit 1：Enrollment \& Screening \& Run-in period Patients who meet the inclusion criteria will be asked to complete IBS Baseline Assessment Questionnaires according to Rome III.Subjects that meet the criteria will receive verbal and written information about the study and provide written informed consent. After meeting with the dietitian and physician who will provide instructions, they will be asked to complete Combined Nutrient and Lactulose Breath Test.[16] Additionally, a baseline food and symptom diary will be completed in a (minimum) 14 day run-in period after breath test (the first 48hr after the breath test will not be included in this analysis). This diary record prior to the intervention will document baseline symptom severity and capture the habitual diet of IBS patients.
Visit 2: Randomization \& Intervention. After the run-in period, patients will come back to the clinic to receive dietary instruction ahead of starting the intervention. At the same visit subjects will provide fresh stool for fermentation analysis (including short chain fatty acids and pressure detection) and blood for cytokines analysis. Subjects will then be randomly assigned to either low FODMAP diet (LFD) group or traditional dietary advice for IBS (TDA) group by computer-generated random number table. Participants will receive food instructions by a dietitian, according to their assignment. Throughout the study, only the dietitian will be aware of the assignment of the intervention given. Both diet therapy will last for 3 weeks, and all the subjects are instructed to complete daily food and symptom diary through a provided booklet. IBS Symptoms Severity Scores (IBS-SSS) is evaluated every week and the dietitian who is not aware of the allocation will make a telephone follow-up to assess patient adherence.
Visit 3: End of treatment \& Follow-up. After 3 weeks of intervention, the participants will attend a follow-up appointment and complete the IBS Post-Intervention Assessment Questionnaires. Fresh stools and blood are recollected at this visit to evaluate for possible change in gut microbiota and cytokines after diet intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-FODMAPs diet | Experimental | Dietary Supplement: low-FODMAPs dietThe low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data. low-FODMAPs diet therapy for 3 weeks |
| Traditional dietary advice | Placebo comparator | Dietary Supplement: Traditional dietary adviceTraditional dietary advice (TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period Traditional dietary advice for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old.
- Meet Rome Rome III criteria for IBS-D.
- All these patients should have no abnormality in blood, stool analysis or colonoscopy within the previous 2 years.
- No GI alarm symptoms.
Key exclusion criteria (8 listed)
- Presence of a severe cardiac, hepatic, nephritic, neurologic disease.
- Presence of mental disorders caused by schizophrenia, organic brain disorder or physical disease.
- Other comorbid medical conditions (eg.unstable diabetes, unstable thyroid disease).
- Previous abdominal surgery except appendectomy or hysterectomy.
- Pregnant or lactating women.
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 dietThe low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data. low-FODMAPs diet therapy for 3 weeks | Dietary supplement | low-FODMAPs diet |
| Traditional dietary adviceTraditional dietary advice(TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period traditional dietary advice for 3 weeks | Dietary supplement | Traditional dietary advice |
Primary outcome
Compare response to diet intervention between different groups.
Time frame: three weeks
Primary endpoint will be response to 3-week of diet intervention defined by shows >50 point reduction in IBS-SSS between baseline and post-intervention scores. The proportion of responders who met primary endpoint in each group will be compared.
12 secondary outcomes
Improvement in abdominal pain between different groups.
Time frame: Three weeks
Improvement in stool consistency between different groups.
Time frame: Three weeks
Compare changes from baseline in abdominal pain score between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in abdominal frequency between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in bloating score between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in excessive wind score between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in stool consistency between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in stool frequency between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in urgency score between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in incomplete defecation score between different groups.
Time frame: Every week, last for three weeks
Compare changes from baseline in quality of life between different groups.
Time frame: Three weeks
Compare changes from baseline in mental health between different groups.
Time frame: Three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 33740048Zhang Y, Feng L, Wang X, Fox M, Luo L, Du L, Chen B, Chen X, He H, Zhu S, Hu Z, Chen S, Long Y, Zhu Y, Xu L, Deng Y, Misselwitz B, Lang BM, Yilmaz B, Kim JJ, Owyang C, Dai N. Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet compared with traditional dietary advice for diarrhea-predominant irritable bowel syndrome: a parallel-group, randomized controlled trial with analysis of clinical and microbiological factors associated with patient outcomes. Am J Clin Nutr. 2021 Jun 1;113(6):1531-1545. doi: 10.1093/ajcn/nqab005.
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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.
Yawen Zhang, MM principal investigator
Sir Run Run Shaw Hospital
Lijun Feng principal investigator
Sir Run Run Shaw Hospital
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 Traditional dietary advice in people with Irritable Bowel Syndrome and Diet Modification, run by Sir Run Run Shaw Hospital 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 8 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: finished, as of the sponsor's last update on 12 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare response to diet intervention between different groups. (time frame: three 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 NCT03304041, which also lists 1 linked publication.
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 12 Sep 2019.