Clinical trial NCT03304041: Efficacy of Low-FODMAPs Dietary Therapy for Irritable Bowel Syndrome in China
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Diet Modification
Keywords: low-FODMAP
Irritable Bowel Syndrome
stool fermentation
Breath test
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Academy of Agricultural Sciences
name: University of Michigan
name: Klinik Arlesheim
First posted: 2017-10-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Compare response to diet intervention between different groups.
timeFrame: three weeks
Secondary outcomes:
measure: Improvement in abdominal pain between different groups.
timeFrame: Three weeks
measure: Improvement in stool consistency between different groups.
timeFrame: Three weeks
measure: Compare changes from baseline in abdominal pain score between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in abdominal frequency between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in bloating score between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in excessive wind score between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in stool consistency between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in stool frequency between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in urgency score between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in incomplete defecation score between different groups.
timeFrame: Every week, last for three weeks
measure: Compare changes from baseline in quality of life between different groups.
timeFrame: Three weeks
measure: Compare changes from baseline in mental health between different groups.
timeFrame: Three weeks
Other outcomes:
measure: Compare group difference about stool fermentation production before and after intervention.
timeFrame: Three weeks
measure: Compare group difference about fecal microbial α- diversity displayed by Shannon index before and after intervention.
timeFrame: Three weeks
measure: Compare group difference about fecal microbial β- diversity displayed by Principal Component Analysis (PCA) before and after intervention.
timeFrame: Three weeks
measure: Compare group difference about fecal microbial communities before and after intervention.
timeFrame: Three weeks
measure: Compare stool microbial α- diversity displayed by Shannon between responders and non-responders
timeFrame: Baseline (0 week)
measure: Compare stool microbial β- diversity displayed by Principal Component Analysis (PCA) between responders and non-responders
timeFrame: Baseline (0 week)
measure: Compare stool microbial communities between responders and non-responders
timeFrame: Baseline (0 week)
measure: Compare stool fermentation production between responders and non-responders
timeFrame: Baseline (0 week)
measure: Compare IBS symptom severity between responders and non-responders
timeFrame: Baseline (0 week)
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University
state: Zhe Jiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yawen Zhang, MM
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Lijun Feng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.